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Archive for the ‘Hypogonadism’ Category

Andropause: Not the same as menopause but needs to be addressed – The Star Online

First of all it is important to make clear that andropause isn't the male version of menopause, says consultant urologist Dr Datesh Daneshwal.

"While all women go through menopause, all men do not experience andropause. It's not supposed to happen to every man and it only affects a very small percentage of men," he says.

Andropause is a condition where men experience a decrease in their testosterone levels that is not normal. While all men do start losing testosterone after the age of 30, the decrease isn't very significant (about 1% a year) and should not affect their well-being. Very different from menopause which signifies a sudden decrease in a womans hormone levels that causes ovulation to cease.

But sometimes, when a man's biochemical dip is more drastic, it can cause a broad range of symptoms that affect their overall health and temperament.

These symptoms include a decline in muscle mass and strength, a buildup of body fat, a loss of bone density, flagging energy, emotional instability, deranged sugar and cholesterol levels, lowered fertility and fading virility.

"A drop in testosterone coupled with these symptoms is what is classified as andropause. When it interferes with your well-being and health," explains Dr Datesh. "Many people have a misconception that testosterone is purely for sexual function which it is not. It is the elixir that keeps the brain sharp, affects one's mood, muscle bulk and weight management and also collesterol and sugar levels. Low testosterone can cause insomnia and depression and, of course, sexual dysfunction too. Men need a certain level of testosterone to function well in all aspects of their life and if it dips too low, their health is at risk," says Dr Datesh

Getting help

David was 38 when he started noticing the symptoms.

"I was experiencing a gradual but progressive decline of erectile function, decreased libido, frequent and more prolonged periods of low moods, decreased energy levels and frustration, sadness and despair that my interest in the opposite gender was not what it once was," says David who is now 61.

Although he initially started taking Viagra to help with his sexual dysfunction, David decided to consult a doctor when the symptoms persisted.

"For many years, l absorbed myself in my work and largely shrugged off and just accepted my symptoms without question. ince retiring a few years ago, l have had the time to become more aware of the physical and psychological fallout these symptoms have been having on me. The biggest psychological symptom was the diminishing confidence that l keenly felt in pursuing new relationships with women (l am, and always have been, a single guy) not least because l was conscious of the increasing difficulty of consummating such relationships.

"On a physical level, l felt myself becoming more anxious and subject to low moods as well as experiencing decreasing energy levels. I felt that l owed it to myself to get my symptoms properly evaluated by qualified professionals in this area," he said.

David was diagnosed with hypogonadism, a condition where the body doesn't produce enough testosterone which can occur from birth or later in life, often from injury or infection. He is currently on testosterone replacement treatment as well as medicine for erectile dysfunction which he says has helped him tremendously.

"Physically, l feel more energised, l have a stronger libido and my erectile functioning difficulties have been greatly improved, with further improvements anticipated after further testosterone injections. Psychologically, my confidence in interacting with women has been greatly boosted l think this is the most dramatic change l have notice.

"My advise to other men who are going through this is to not ignore the symptoms but to take action! Go and get specialist advice initially from your doctor and better still from a Urologist who has special expertise in this area. Please do not be embarrassed about talking through your symptoms with a doctor or urologist, particularly around erectile dysfunction. Remember that these medical people have seen and heard it all before many, many times. ln most cases your symptoms are likely to be physiological rather than psychological and can be resolved with treatment," says David.

Strength training exercises and a healthy lifestyle can stimulate the body's own production of testosterone. Photo: Pixabay

The stigma is real

Although there is a lot of literature available or andropause, men rarely seek medical help even when the symptoms can be affecting their life significantly, notes Dr Datesh.

"There is a stigma associated with this, unfortunately. And that's because we immediately associate testosterone with sexual function. That's why we need to raise awareness about how men need healthy levels of testosterone to lead a healthy life all around. If you are over 40 and are not feeling yourself notice that you put on weight, lose muscle bulk, emotional instability, find you are no longer attracted to your partner anymore, come and get tested. All it takes is a simple blood test and if it is because of low levels of testosterone, there is a solution now. You can get treated and change your life not just for yourself but for your family too," says the urologist from Prince Court Medical Centre.

Hormone replacement therapies for men come in the forms of pills, injections and gels although the most effective and popular option in Malaysia are thelong-term injections that are adinistered every three months.

"Hormone replacement is a science though and cannot be administered simply without ruling out a few things. First and most importantly, we have to make sure that the patient has no signs of prostate cancer because testosterone is fuel for prostate cancer cells. Second, while testosterone administered externally may help with a man's virility, it may affect his fertility. These things have to be discussed with the patient before he starts on treatment," says Dr Datesh.

How long a patient has to be on them really depends on the individual, he says.

I have had patients who, after a couple of doses, were feeling better and able to resume an active lifestyle which can stimulate the body's ability to produce it's own testosterone," he explains.

Men experiencing the symptoms of andropause are advised to make healthier lifestyle choices. Aerobic exercise to release endorphins that improve mood, strength training to increase blood flow and strengthen the hear as well a healthy diet and a decrease in alcohol and tobacco intake.

Muscle-building exercises, he says, can encourage the body's own production of testosterone.

"But a person experiencing andropause will not have the energy to do weight training - they'd need a boost of hormones get they them feeling energised enough to start exercising and building their body up," he says.

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Andropause: Not the same as menopause but needs to be addressed - The Star Online

Exelixis Announces Takeda and Ono Submit Supplemental Application for CABOMETYX (cabozantinib) in Combination with OPDIVO (nivolumab) for the…

Oct. 27, 2020 05:02 UTC

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (NASDAQ: EXEL) today announced that Takeda Pharmaceutical Company Limited (Takeda), its partner responsible for the clinical development and commercialization of CABOMETYX (cabozantinib) in Japan, and Ono Pharmaceutical Co., Ltd. (Ono), have submitted a supplemental application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for Manufacturing and Marketing approval of CABOMETYX in combination with OPDIVO (nivolumab) for the treatment of patients with unresectable, advanced or metastatic renal cell carcinoma (RCC).

Takeda and Onos application is based on the results of CheckMate -9ER, a phase 3 pivotal trial evaluating CABOMETYX in combination with OPDIVO in previously untreated patients with advanced or metastatic RCC compared with sunitinib. In CheckMate -9ER, CABOMETYX in combination with OPDIVO demonstrated superior overall survival, doubled median progression-free survival and objective response rate, and demonstrated a favorable safety profile versus sunitinib. These results were presented as a Proffered Paper during a Presidential Symposium at the European Society for Medical Oncology Virtual Congress 2020.

Following our recent announcement that the U.S. FDA accepted and granted Priority Review to our supplemental new drug application for CABOMETYX in combination with OPDIVO for the treatment of advanced renal cell carcinoma, were excited that our partner Takeda along with Ono have also advanced this combination regimen toward potential regulatory approval in Japan, said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. The results of the CheckMate -9ER trial suggest CABOMETYX in combination with OPDIVO may become an important new treatment option for patients with advanced kidney cancer in need of new therapies.

Per the terms of Exelixis and Takedas collaboration and license agreement, Exelixis is eligible to receive a $10 million milestone payment from Takeda as a result of this latest submission for RCC. Following the milestone associated with this regulatory filing, Exelixis will be eligible to receive a first-sale milestone payment of $20 million from Takeda related to the combination of CABOMETYX and OPDIVO for the treatment of RCC. Exelixis continues to be eligible to receive additional development, regulatory and first-sale milestones for potential future cabozantinib indications, and is also eligible for sales revenue milestones and royalties on net sales of cabozantinib in Japan. Takeda fully funds cabozantinib development activities that are exclusively for the benefit of Japan and has the opportunity to share the costs associated with global cabozantinib clinical trials, providing the company opts into those trials.

Takeda received approval in March 2020 from the Japanese MHLW to manufacture and market CABOMETYX as a treatment for patients with curatively unresectable or metastatic RCC.

About CheckMate -9ER

CheckMate -9ER is an open-label, randomized, multi-national phase 3 trial evaluating patients with previously untreated advanced or metastatic RCC. A total of 651 patients (23% favorable risk, 58% intermediate risk, 20% poor risk; 25% PD-L11%) were randomized to receive OPDIVO plus CABOMETYX (n=323) vs. sunitinib (n=328). The primary endpoint is progression-free survival. Secondary endpoints include overall survival and objective response rate. The primary efficacy analysis is comparing the doublet combination vs. sunitinib in all randomized patients. The trial is sponsored by Bristol Myers Squibb and Ono Pharmaceutical Co. and co-funded by Exelixis, Ipsen and Takeda Pharmaceutical Company Limited.

About RCC

The American Cancer Societys 2020 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.1 Clear cell RCC is the most common type of kidney cancer in adults.2 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 12%.2 Approximately 32,000 patients in the U.S. and 71,000 worldwide will require systemic treatment for advanced kidney cancer in 2020.3

About 70% of RCC cases are known as clear cell carcinomas, based on histology.4 The majority of clear cell RCC tumors have below-normal levels of a protein called von Hippel-Lindau, which leads to higher levels of MET, AXL and VEGF.5,6 These proteins promote tumor angiogenesis (blood vessel growth), growth, invasiveness and metastasis.7,8,9,10 MET and AXL may provide escape pathways that drive resistance to VEGF receptor inhibitors.6,7

About CABOMETYX (cabozantinib)

In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC and for the treatment of patients with HCC who have been previously treated with sorafenib. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the United States.

CABOMETYX in combination with OPDIVO is not indicated for advanced RCC.

CABOMETYX Important Safety Information

Warnings and Precautions

Hemorrhage: Severe and fatal hemorrhages occurred with CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies. Discontinue CABOMETYX for Grade 3 or 4 hemorrhage. Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.

Perforations and Fistulas: Gastrointestinal (GI) perforations, including fatal cases, occurred in 1% of CABOMETYX patients. Fistulas, including fatal cases, occurred in 1% of CABOMETYX patients. Monitor patients for signs and symptoms of perforations and fistulas, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a Grade 4 fistula or a GI perforation.

Thrombotic Events: CABOMETYX increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events occurred in CABOMETYX patients. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic event requiring medical intervention.

Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension occurred in 36% (17% Grade 3 and <1% Grade 4) of CABOMETYX patients. Do not initiate CABOMETYX in patients with uncontrolled hypertension. Monitor blood pressure regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Diarrhea: Diarrhea occurred in 63% of CABOMETYX patients. Grade 3 diarrhea occurred in 11% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be managed with standard antidiarrheal treatments, or Grade 4 diarrhea.

Palmar-Plantar Erythrodysesthesia (PPE): PPE occurred in 44% of CABOMETYX patients. Grade 3 PPE occurred in 13% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.

Proteinuria: Proteinuria occurred in 7% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. Discontinue CABOMETYX in patients who develop nephrotic syndrome.

Osteonecrosis of the Jaw (ONJ): ONJ occurred in <1% of CABOMETYX patients. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain, or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to CABOMETYX initiation and periodically during treatment. Advise patients regarding good oral hygiene practices. Withhold CABOMETYX for at least 3 weeks prior to scheduled dental surgery or invasive dental procedures, if possible. Withhold CABOMETYX for development of ONJ until complete resolution.

Impaired Wound Healing: Wound complications occurred with CABOMETYX. Withhold CABOMETYX for at least 3 weeks prior to elective surgery. Do not administer CABOMETYX for at least 2 weeks after major surgery and until adequate wound healing is observed. The safety of resumption of CABOMETYX after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic findings on MRI, can occur with CABOMETYX. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.

Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to initiating CABOMETYX and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

The most commonly reported (25%) adverse reactions are: diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, and vomiting.

Drug Interactions

Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.

Strong CYP3A4 Inducers: If coadministration with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage. Avoid St. Johns wort.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during CABOMETYX treatment and for 4 months after the final dose.

Hepatic Impairment: In patients with moderate hepatic impairment, reduce the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with severe hepatic impairment.

Please see accompanying full Prescribing Information https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.

OPDIVO INDICATIONS

OPDIVO (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO (nivolumab) is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).

OPDIVO (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

OPDIVO (nivolumab) is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not be inclusive of all possible severe and fatal immune-mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur at any time after starting or discontinuing YERVOY. Early identification and management are essential to ensure safe use of YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue YERVOY depending on severity. In general, if YERVOY requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less followed by corticosteroid taper for at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroid therapy. Institute hormone replacement therapy for endocrinopathies as warranted.

Immune-Mediated Pneumonitis

OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 6% (25/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 10% (5/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 4.4% (24/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 1.7% (2/119) of patients. In NSCLC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%) immune-mediated pneumonitis. Four patients (0.7%) died due to pneumonitis. The incidence and severity of immune-mediated pneumonitis in patients with NSCLC treated with OPDIVO 360 mg every 3 weeks in combination with YERVOY 1 mg/kg every 6 weeks and 2 cycles of platinum-doublet chemotherapy were comparable to treatment with OPDIVO in combination with YERVOY only. The incidence and severity of immune-mediated pneumonitis in patients with malignant pleural mesothelioma treated with OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks were similar to those occurring in NSCLC.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated colitis occurred in 10% (5/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 10% (52/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 7% (8/119) of patients.

In a separate Phase 3 trial of YERVOY 3 mg/kg, immune-mediated diarrhea/colitis occurred in 12% (62/511) of patients, including Grade 3-5 (7%).

Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Addition of an alternative immunosuppressive agent to the corticosteroid therapy, or replacement of the corticosteroid therapy, should be considered in corticosteroid-refractory immune-mediated colitis if other causes are excluded.

Immune-Mediated Hepatitis

OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. For patients without HCC, withhold OPDIVO for Grade 2 and permanently discontinue OPDIVO for Grade 3 or 4. For patients with HCC, withhold OPDIVO and administer corticosteroids if AST/ALT is within normal limits at baseline and increases to >3 and up to 5 times the upper limit of normal (ULN), if AST/ALT is >1 and up to 3 times ULN at baseline and increases to >5 and up to 10 times the ULN, and if AST/ALT is >3 and up to 5 times ULN at baseline and increases to >8 and up to 10 times the ULN. Permanently discontinue OPDIVO and administer corticosteroids if AST or ALT increases to >10 times the ULN or total bilirubin increases >3 times the ULN. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 13% (51/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 20% (10/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 7% (38/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 8% (10/119) of patients.

In Checkmate 040, immune-mediated hepatitis requiring systemic corticosteroids occurred in 5% (8/154) of patients receiving OPDIVO.

In a separate Phase 3 trial of YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 4.1% (21/511) of patients, including Grade 3-5 (1.6%).

Immune-Mediated Endocrinopathies

OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Withhold for Grades 2, 3, or 4 endocrinopathies if not clinically stable. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 9% (36/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 4% (2/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypophysitis occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hypophysitis occurred in 3.4% (4/119) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency occurred in 5% (21/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency occurred in 18% (9/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 7% (41/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 5.9% (7/119) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving this dose of OPDIVO with YERVOY. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (11/49) of patients. Hyperthyroidism occurred in 10% (5/49) of patients receiving this dose of OPDIVO with YERVOY. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (119/547) of patients. Hyperthyroidism occurred in 12% (66/547) of patients receiving this dose of OPDIVO with YERVOY. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 15% (18/119) of patients. Hyperthyroidism occurred in 12% (14/119) of patients. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, diabetes occurred in 1.5% (6/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, diabetes occurred in 2.7% (15/547) of patients.

In a separate Phase 3 trial of YERVOY 3 mg/kg, severe to life-threatening endocrinopathies occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were hospitalized for severe endocrinopathies.

Immune-Mediated Nephritis and Renal Dysfunction

OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 1.7% (2/119) of patients.

Immune-Mediated Skin and Dermatologic Adverse Reactions

OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated rash occurred in 22.6% (92/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated rash occurred in 35% (17/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated rash occurred in 16% (90/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated rash occurred in 14% (17/119) of patients.

YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous exfoliative rashes. Withhold YERVOY until specialist assessment for Grade 2 and permanently discontinue for Grade 3 or 4 exfoliative or bullous dermatologic conditions.

In a separate Phase 3 trial of YERVOY 3 mg/kg, immune-mediated rash occurred in 15% (76/511) of patients, including Grade 3-5 (2.5%).

Immune-Mediated Encephalitis

OPDIVO can cause immune-mediated encephalitis. Fatal cases have been reported. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids. Encephalitis occurred in one melanoma patient receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg (0.2%) after 1.7 months of exposure. Encephalitis occurred in one RCC patient receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg (0.2%) after approximately 4 months of exposure. Encephalitis occurred in one MSI-H/dMMR mCRC patient (0.8%) receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg after 15 days of exposure.

Other Immune-Mediated Adverse Reactions

Based on the severity of the adverse reaction, permanently discontinue or withhold OPDIVO, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Dose modifications for YERVOY for adverse reactions that require management different from these general guidelines are summarized as follows. Withhold for Grade 2 and permanently discontinue YERVOY for Grade 3 or 4 neurological toxicities. Withhold for Grade 2 and permanently discontinue YERVOY for Grade 3 or 4 myocarditis. Permanently discontinue YERVOY for Grade 2, 3, or 4 ophthalmologic adverse reactions that do not improve to Grade 1 within 2 weeks while receiving topical therapy OR that require systemic therapy. Across clinical trials of OPDIVO monotherapy or in combination with YERVOY , the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1.0% of patients receiving OPDIVO: myocarditis, rhabdomyolysis, myositis, uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barr syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), motor dysfunction, vasculitis, aplastic anemia, pericarditis, myasthenic syndrome, hemophagocytic lymphohistiocytosis (HLH), and autoimmune hemolytic anemia. In addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1% of patients unless otherwise specified: autoimmune neuropathy (2%), meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis, nerve paresis, angiopathy, temporal arteritis, pancreatitis (1.3%), arthritis, polymyositis, conjunctivitis, cytopenias (2.5%), eosinophilia (2.1%), erythema multiforme, hypersensitivity vasculitis, neurosensory hypoacusis, psoriasis, blepharitis, episcleritis, orbital myositis, scleritis, and solid organ transplant rejection. Some cases of ocular IMARs have been associated with retinal detachment.

If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, which has been observed in patients receiving OPDIVO and YERVOY and may require treatment with systemic steroids to reduce the risk of permanent vision loss.

Infusion-Related Reactions

OPDIVO can cause severe infusion-related reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion-related reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. Severe infusion-related reactions can also occur with YERVOY. Discontinue YERVOY in patients with severe or life-threatening infusion reactions and interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate trial in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, infusion-related reactions occurred in 8% (4/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 5.1% (28/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 4.2% (5/119) of patients. In MPM patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, infusion-related reactions occurred in 12% (37/300) of patients.

In separate Phase 3 trials of YERVOY 3 mg/kg and 10 mg/kg, infusion-related reactions occurred in 2.9% (28/982).

Complications of Allogeneic Hematopoietic Stem Cell Transplantation

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1 receptor blocking antibody or YERVOY. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1 or CTLA-4 receptor blockade and allogeneic HSCT.

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1 receptor blocking antibody or YERVOY prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on mechanism of action, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO or YERVOY and for at least 5 months after the last dose.

Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone

In clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Lactation

It is not known whether OPDIVO or YERVOY is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from OPDIVO or YERVOY, advise women not to breastfeed during treatment and for at least 5 months after the last dose.

Serious Adverse Reactions

In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in 2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and 36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%), colitis (10% and 1.9%), and pyrexia (10% and 1.0%). In Checkmate 227, serious adverse reactions occurred in 58% of patients (n=576). The most frequent (2%) serious adverse reactions were pneumonia, diarrhea/colitis, pneumonitis, hepatitis, pulmonary embolism, adrenal insufficiency, and hypophysitis. Fatal adverse reactions occurred in 1.7% of patients; these included events of pneumonitis (4 patients), myocarditis, acute kidney injury, shock, hyperglycemia, multi-system organ failure, and renal failure. In Checkmate 9LA, serious adverse reactions occurred in 57% of patients (n=358). The most frequent (>2%) serious adverse reactions were pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis, and respiratory failure. Fatal adverse reactions occurred in 7 (2%) patients, and included hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia, and massive hemoptysis in the setting of thrombocytopenia. In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in 2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 032, serious adverse reactions occurred in 45% of patients receiving OPDIVO (n=245). The most frequent serious adverse reactions reported in 2% of patients receiving OPDIVO were pneumonia, dyspnea, pneumonitis, pleural effusion, and dehydration. In Checkmate 743, serious adverse reactions occurred in 54% of patients receiving OPDIVO plus YERVOY. The most frequent serious adverse reactions reported in 2% of patients were pneumonia, pyrexia, diarrhea, pneumonitis, pleural effusion, dyspnea, acute kidney injury, infusion-related reaction, musculoskeletal pain, and pulmonary embolism. Fatal adverse reactions occurred in 4 (1.3%) patients and included pneumonitis, acute heart failure, sepsis, and encephalitis. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in 2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 214, serious adverse reactions occurred in 59% of patients receiving OPDIVO plus YERVOY. The most frequent serious adverse reactions reported in 2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis. In Checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in 1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last OPDIVO dose, 2 from infection 8 to 9 months after completing OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=236). The most frequent serious adverse reactions reported in 2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in 2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration. In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY, serious adverse reactions occurred in 47% of patients. The most frequent serious adverse reactions reported in 2% of patients were colitis/diarrhea, hepatic events, abdominal pain, acute kidney injury, pyrexia, and dehydration. In Checkmate 040, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=154). The most frequent serious adverse reactions reported in 2% of patients were pyrexia, ascites, back pain, general physical health deterioration, abdominal pain, pneumonia, and anemia. In Checkmate 040, serious adverse reactions occurred in 59% of patients receiving OPDIVO with YERVOY (n=49). Serious adverse reactions reported in 4% of patients were pyrexia, diarrhea, anemia, increased AST, adrenal insufficiency, ascites, esophageal varices hemorrhage, hyponatremia, increased blood bilirubin, and pneumonitis. In Checkmate 238, Grade 3 or 4 adverse reactions occurred in 25% of OPDIVO-treated patients (n=452). The most frequent Grade 3 and 4 adverse reactions reported in 2% of OPDIVO-treated patients were diarrhea and increased lipase and amylase. Serious adverse reactions occurred in 18% of OPDIVO-treated patients. In Attraction-3, serious adverse reactions occurred in 38% of patients receiving OPDIVO (n=209). Serious adverse reactions reported in 2% of patients who received OPDIVO were pneumonia, esophageal fistula, interstitial lung disease and pyrexia. The following fatal adverse reactions occurred in patients who received OPDIVO: interstitial lung disease or pneumonitis (1.4%), pneumonia (1.0%), septic shock (0.5%), esophageal fistula (0.5%), gastrointestinal hemorrhage (0.5%), pulmonary embolism (0.5%), and sudden death (0.5%).

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Exelixis Announces Takeda and Ono Submit Supplemental Application for CABOMETYX (cabozantinib) in Combination with OPDIVO (nivolumab) for the...

Hormone Replacement Drugs Market Overview With Detailed Analysis, Competitive Landscape, Forecast to 2026|Eli Lilly, Pfizer, AbbVie – Eurowire

Hormone Replacement Drugs Market Insights, Forecast to 2026

Complete study of the global Hormone Replacement Drugs market is carried out by the analysts in this report, taking into consideration key factors like drivers, challenges, recent trends, opportunities, advancements, and competitive landscape. This report offers a clear understanding of the present as well as future scenario of the global Hormone Replacement Drugs industry. Research techniques like PESTLE and Porters Five Forces analysis have been deployed by the researchers. They have also provided accurate data on Hormone Replacement Drugs production, capacity, price, cost, margin, and revenue to help the players gain a clear understanding into the overall existing and future market situation.

Key companies operating in the global Hormone Replacement Drugs market include Eli Lilly, Pfizer, AbbVie, Novo Nordisk, Merck KGaA, Mylan, Bayer, Teva, Novartis, Abbott, Roche, Endo International, Ipsen, ANI Pharmaceuticals, TherapeuticsMD

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Segmental Analysis

The report has classified the global Hormone Replacement Drugs industry into segments including product type and application. Every segment is evaluated based on growth rate and share. Besides, the analysts have studied the potential regions that may prove rewarding for the Hormone Replacement Drugs manufcaturers in the coming years. The regional analysis includes reliable predictions on value and volume, thereby helping market players to gain deep insights into the overall Hormone Replacement Drugs industry.

Segmentation

Description

By Product Type

Hormone replacement drugs refers to the treatment of the patients with hormone deficiency due to conditions such as dwarfism or women nearing menopause, which requires replacement of hormones in the body whose levels have become low.Market Analysis and Insights: Global Hormone Replacement Drugs MarketThe global Hormone Replacement Drugs market size is projected to reach US$ XX million by 2026, from US$ XX million in 2020, at a CAGR of XX%% during 2021-2026.Global Hormone Replacement Drugs Scope and SegmentThe global Hormone Replacement Drugs market is segmented by company, region (country), by Type, and

By Application

Hormone replacement drugs refers to the treatment of the patients with hormone deficiency due to conditions such as dwarfism or women nearing menopause, which requires replacement of hormones in the body whose levels have become low.Market Analysis and Insights: Global Hormone Replacement Drugs MarketThe global Hormone Replacement Drugs market size is projected to reach US$ XX million by 2026, from US$ XX million in 2020, at a CAGR of XX%% during 2021-2026.Global Hormone Replacement Drugs Scope and SegmentThe global Hormone Replacement Drugs market is segmented by company, region (country), by Type, and by Application. Players, stakeholders, and other participants in the global Hormone Replacement Drugs market will be able to gain the upper hand as they use the report as a powerful resource. The segmental analysis focuses on revenue and forecast by region (country), by Type, and by Application for the period 2015-2026.The major regions covered in the report are North America, Europe, China, Rest of Asia Pacific, Central & South America, Middle East & Africa, etc. It includes revenue analysis of each region for the year 2015 to 2026.By the type, the market is primarily split into, Estrogen Hormone, Growth Hormone, Thyroid Hormone, Testosterone HormoneBy the application, this report covers the following segments, Menopause, Hypothyroidism, Growth Hormone Deficiency, Male Hypogonadism, Other DiseasesCompetitive Landscape:The Hormone Replacement Drugs key manufacturers in this market include:, Eli Lilly, Pfizer, AbbVie, Novo Nordisk, Merck KGaA, Mylan, Bayer, Teva, Novartis, Abbott, Roche, Endo International, Ipsen, ANI Pharmaceuticals, TherapeuticsMD

Some of the Top Key player Operating in The Report Are

Eli Lilly, Pfizer, AbbVie, Novo Nordisk, Merck KGaA, Mylan, Bayer, Teva, Novartis, Abbott, Roche, Endo International, Ipsen, ANI Pharmaceuticals, TherapeuticsMD

By Region

North America

oU.S.

oCanada

Europe

oGermany

oU.K.

oFrance

oItaly

oSpain

oRest of Europe

Asia Pacific

oChina

oIndia

oJapan

oRest of Asia Pacific

Middle East & Africa

oGCC

oSouth Africa

oRest of Middle East & Africa

Latin America

oBrazil

oMexico

oRest of Latin America

Competitive Landscape

It is important for every market participant to be familiar with the competitive scenario in the global Hormone Replacement Drugs industry. In order to fulfill the requirements, the industry analysts have evaluated the strategic activities of the competitors to help the key players strengthen their foothold in the market and increase their competitiveness.

Key questions answered in the report:

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Table of Contents

1 Market Overview of Hormone Replacement Drugs1.1 Hormone Replacement Drugs Market Overview1.1.1 Hormone Replacement Drugs Product Scope1.1.2 Market Status and Outlook1.2 Global Hormone Replacement Drugs Market Size Overview by Region 2015 VS 2020 VS 20261.3 Global Hormone Replacement Drugs Market Size by Region (2015-2026)1.4 Global Hormone Replacement Drugs Historic Market Size by Region (2015-2020)1.5 Global Hormone Replacement Drugs Market Size Forecast by Region (2021-2026)1.6 Key Regions, Hormone Replacement Drugs Market Size YoY Growth (2015-2026)1.6.1 North America Hormone Replacement Drugs Market Size YoY Growth (2015-2026)1.6.2 Europe Hormone Replacement Drugs Market Size YoY Growth (2015-2026)1.6.3 China Hormone Replacement Drugs Market Size YoY Growth (2015-2026)1.6.4 Rest of Asia Pacific Hormone Replacement Drugs Market Size YoY Growth (2015-2026)1.6.5 Latin America Hormone Replacement Drugs Market Size YoY Growth (2015-2026)1.6.6 Middle East & Africa Hormone Replacement Drugs Market Size YoY Growth (2015-2026)

2 Hormone Replacement Drugs Market Overview by Type2.1 Global Hormone Replacement Drugs Market Size by Type: 2015 VS 2020 VS 20262.2 Global Hormone Replacement Drugs Historic Market Size by Type (2015-2020)2.3 Global Hormone Replacement Drugs Forecasted Market Size by Type (2021-2026)2.4 Estrogen Hormone2.5 Growth Hormone2.6 Thyroid Hormone2.7 Testosterone Hormone

3 Hormone Replacement Drugs Market Overview by Application3.1 Global Hormone Replacement Drugs Market Size by Application: 2015 VS 2020 VS 20263.2 Global Hormone Replacement Drugs Historic Market Size by Application (2015-2020)3.3 Global Hormone Replacement Drugs Forecasted Market Size by Application (2021-2026)3.4 Menopause3.5 Hypothyroidism3.6 Growth Hormone Deficiency3.7 Male Hypogonadism3.8 Other Diseases

4 Global Hormone Replacement Drugs Competition Analysis by Players4.1 Global Hormone Replacement Drugs Market Size (Million US$) by Players (2015-2020)4.2 Global Top Manufacturers by Company Type (Tier 1, Tier 2 and Tier 3) (based on the Revenue in Hormone Replacement Drugs as of 2019)4.3 Date of Key Manufacturers Enter into Hormone Replacement Drugs Market4.4 Global Top Players Hormone Replacement Drugs Headquarters and Area Served4.5 Key Players Hormone Replacement Drugs Product Solution and Service4.6 Competitive Status4.6.1 Hormone Replacement Drugs Market Concentration Rate4.6.2 Mergers & Acquisitions, Expansion Plans

5 Company (Top Players) Profiles and Key Data5.1 Eli Lilly5.1.1 Eli Lilly Profile5.1.2 Eli Lilly Main Business and Companys Total Revenue5.1.3 Eli Lilly Products, Services and Solutions5.1.4 Eli Lilly Revenue (US$ Million) (2015-2020)5.1.5 Eli Lilly Recent Development and Reaction to Covid-195.2 Pfizer5.2.1 Pfizer Profile5.2.2 Pfizer Main Business and Companys Total Revenue5.2.3 Pfizer Products, Services and Solutions5.2.4 Pfizer Revenue (US$ Million) (2015-2020)5.2.5 Pfizer Recent Development and Reaction to Covid-195.3 AbbVie5.5.1 AbbVie Profile5.3.2 AbbVie Main Business and Companys Total Revenue5.3.3 AbbVie Products, Services and Solutions5.3.4 AbbVie Revenue (US$ Million) (2015-2020)5.3.5 Novo Nordisk Recent Development and Reaction to Covid-195.4 Novo Nordisk5.4.1 Novo Nordisk Profile5.4.2 Novo Nordisk Main Business and Companys Total Revenue5.4.3 Novo Nordisk Products, Services and Solutions5.4.4 Novo Nordisk Revenue (US$ Million) (2015-2020)5.4.5 Novo Nordisk Recent Development and Reaction to Covid-195.5 Merck KGaA5.5.1 Merck KGaA Profile5.5.2 Merck KGaA Main Business and Companys Total Revenue5.5.3 Merck KGaA Products, Services and Solutions5.5.4 Merck KGaA Revenue (US$ Million) (2015-2020)5.5.5 Merck KGaA Recent Development and Reaction to Covid-195.6 Mylan5.6.1 Mylan Profile5.6.2 Mylan Main Business and Companys Total Revenue5.6.3 Mylan Products, Services and Solutions5.6.4 Mylan Revenue (US$ Million) (2015-2020)5.6.5 Mylan Recent Development and Reaction to Covid-195.7 Bayer5.7.1 Bayer Profile5.7.2 Bayer Main Business and Companys Total Revenue5.7.3 Bayer Products, Services and Solutions5.7.4 Bayer Revenue (US$ Million) (2015-2020)5.7.5 Bayer Recent Development and Reaction to Covid-195.8 Teva5.8.1 Teva Profile5.8.2 Teva Main Business and Companys Total Revenue5.8.3 Teva Products, Services and Solutions5.8.4 Teva Revenue (US$ Million) (2015-2020)5.8.5 Teva Recent Development and Reaction to Covid-195.9 Novartis5.9.1 Novartis Profile5.9.2 Novartis Main Business and Companys Total Revenue5.9.3 Novartis Products, Services and Solutions5.9.4 Novartis Revenue (US$ Million) (2015-2020)5.9.5 Novartis Recent Development and Reaction to Covid-195.10 Abbott5.10.1 Abbott Profile5.10.2 Abbott Main Business and Companys Total Revenue5.10.3 Abbott Products, Services and Solutions5.10.4 Abbott Revenue (US$ Million) (2015-2020)5.10.5 Abbott Recent Development and Reaction to Covid-195.11 Roche5.11.1 Roche Profile5.11.2 Roche Main Business and Companys Total Revenue5.11.3 Roche Products, Services and Solutions5.11.4 Roche Revenue (US$ Million) (2015-2020)5.11.5 Roche Recent Development and Reaction to Covid-195.12 Endo International5.12.1 Endo International Profile5.12.2 Endo International Main Business and Companys Total Revenue5.12.3 Endo International Products, Services and Solutions5.12.4 Endo International Revenue (US$ Million) (2015-2020)5.12.5 Endo International Recent Development and Reaction to Covid-195.13 Ipsen5.13.1 Ipsen Profile5.13.2 Ipsen Main Business and Companys Total Revenue5.13.3 Ipsen Products, Services and Solutions5.13.4 Ipsen Revenue (US$ Million) (2015-2020)5.13.5 Ipsen Recent Development and Reaction to Covid-195.14 ANI Pharmaceuticals5.14.1 ANI Pharmaceuticals Profile5.14.2 ANI Pharmaceuticals Main Business and Companys Total Revenue5.14.3 ANI Pharmaceuticals Products, Services and Solutions5.14.4 ANI Pharmaceuticals Revenue (US$ Million) (2015-2020)5.14.5 ANI Pharmaceuticals Recent Development and Reaction to Covid-195.15 TherapeuticsMD5.15.1 TherapeuticsMD Profile5.15.2 TherapeuticsMD Main Business and Companys Total Revenue5.15.3 TherapeuticsMD Products, Services and Solutions5.15.4 TherapeuticsMD Revenue (US$ Million) (2015-2020)5.15.5 TherapeuticsMD Recent Development and Reaction to Covid-19

6 North America Hormone Replacement Drugs by Players and by Application6.1 North America Hormone Replacement Drugs Market Size and Market Share by Players (2015-2020)6.2 North America Hormone Replacement Drugs Market Size by Application (2015-2020)

7 Europe Hormone Replacement Drugs by Players and by Application7.1 Europe Hormone Replacement Drugs Market Size and Market Share by Players (2015-2020)7.2 Europe Hormone Replacement Drugs Market Size by Application (2015-2020)

8 China Hormone Replacement Drugs by Players and by Application8.1 China Hormone Replacement Drugs Market Size and Market Share by Players (2015-2020)8.2 China Hormone Replacement Drugs Market Size by Application (2015-2020)

9 Rest of Asia Pacific Hormone Replacement Drugs by Players and by Application9.1 Rest of Asia Pacific Hormone Replacement Drugs Market Size and Market Share by Players (2015-2020)9.2 Rest of Asia Pacific Hormone Replacement Drugs Market Size by Application (2015-2020)

10 Latin America Hormone Replacement Drugs by Players and by Application10.1 Latin America Hormone Replacement Drugs Market Size and Market Share by Players (2015-2020)10.2 Latin America Hormone Replacement Drugs Market Size by Application (2015-2020)

11 Middle East & Africa Hormone Replacement Drugs by Players and by Application11.1 Middle East & Africa Hormone Replacement Drugs Market Size and Market Share by Players (2015-2020)11.2 Middle East & Africa Hormone Replacement Drugs Market Size by Application (2015-2020)

12 Hormone Replacement Drugs Market Dynamics12.1 Covid-19 Impact: Industry Trends12.2 Covid-19 Impact: Market Drivers12.3 Covid-19 Impact: Market Challenges12.4 Porters Five Forces Analysis

13 Research Finding /Conclusion

14 Methodology and Data Source14.1 Methodology/Research Approach14.1.1 Research Programs/Design14.1.2 Market Size Estimation14.1.3 Market Breakdown and Data Triangulation14.2 Data Source14.2.1 Secondary Sources14.2.2 Primary Sources14.3 Disclaimer14.4 Author List

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Hormone Replacement Drugs Market Overview With Detailed Analysis, Competitive Landscape, Forecast to 2026|Eli Lilly, Pfizer, AbbVie - Eurowire

The Anabolic Steroids market to go the reverse transversal way in the next decade – The Think Curiouser

Anabolic steroids additionally called androgenic steroids are derivatives of testosterone, significant for advancing and keeping up muscle development and creating auxiliary male sex qualities, for example, an extending voice and facial hair. They are anabolic and increment protein inside cells, particularly in skeletal muscles, Anabolic steroids utilized restoratively in ailments to animate muscle increment, set off male adolescence and treat constant squandering conditions, comprising of malignancy and AIDS.

Increment in geriatric populace drives the androgens and anabolic steroids commercial center, as more men are susceptible to hypogonadism. Also, ascend in weight issues in men propels the overall androgens and anabolic steroids market. The growing negative health status specifically within the developing countries is projected to fuel the growth of the marketplace during the forecast period. Besides, rise in government ventures for higher human services is attributed to the growth of the overall androgens and anabolic steroids market. Increment in occurrence of hypogonadism among men is anticipated to enlarge the worldwide androgens and anabolic steroids market all through the forecast span. Rise in impotence among men due to weight problems and tiredness is expected to enhance demand for androgens and anabolic steroids during forecast duration.

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Anabolic Steroids Market can be segmented on basis of compound derivatives, mode of administration, applications, Distribution channels and geography.

On basis of synthetic derivatives, Anabolic steroids market is segmented as:

On basis of Modes of administration, Anabolic steroids is segmented as:

On basis of Applications, anabolic steroids is segmented as:

On basis of Distribution channels, anabolic steroids market is segmented as:

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Anabolic steroids include di-hydro-testosterone, testosterone, and other marketers. Anabolic steroids stimulate the improvement of male sex organs and male sexual characters including growth of beard and deepening of voice. Various varieties of tissues grow due to stimulation of anabolic steroids, specifically muscle and bone. Rise in red blood cells production is due to anabolic results. Androgens and anabolic steroids are used for the remedy of breast cancer in ladies, impotence, hypogonadism in men, and alternative therapy delayed puberty in adolescent boys. Anabolic steroids are also used for the treatment of numerous conditions with hormonal imbalance, weight loss, osteoporosis, and anemia. Anabolic steroids market can be segmented based on synthetic derivatives, mode of administration, application, end-user, and region. In terms of mode of administration, the market can be categorized into oral, injection, topical, skin patches and inhaler. Based on application type, anabolic steroids market can be divided into Anabolic, Androgenic and others. Based on distribution channels anabolic steroids market can be classified into hospital pharmacies, retail pharmacies and online pharmacies. The hospital pharmacies segment dominated the market owing to elevated availability of medications and hospitals being the first point of contact for treatment.

Anabolic steroids market in North America held the biggest marketplace share due to expanded prevalence of breast cancer in women. According to many researches, breast cancers is one of the main cause of death in U.S. Europe held the second largest share in anabolic steroids market because of accelerated occurrence of hypogonadism in men and delayed puberty in adolescent boys. The Anabolic steroids market in Asia Pacific is expected to grow at a fast pace during the forecast period attributable to multiplied government initiatives to get rid of breast cancer. Anabolic steroids market in Middle East & Africa is predicted to be driven via improved occurrence of impotence, hypogonadism in men, and behind schedule puberty in adolescent boys. The market in Latin America is projected to witness robust increase at some point of the forecast length due to accelerated government tasks within the fitness care sector.

Valeant, Endo Pharmaceuticals Solutions Inc., Germiphene Corporation, Taro Pharmaceuticals, Inc., Antares Pharma, Inc, Actavis Pharma, Inc, Sandoz, Pfizer, Unimed Pharmaceuticals, Upsher-Smith and others

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The Anabolic Steroids market to go the reverse transversal way in the next decade - The Think Curiouser

EffRx Pharmaceuticals Signs Exclusive License Agreement with Diurnal for the Registration and Commercialization of Alkindi and Submits Market…

Oct. 21, 2020 11:00 UTC

FREIENBACH, Switzerland--(BUSINESS WIRE)-- EffRxSA, a commercial-stage company that commercializes niche and orphan medicines in Switzerland and Europe, today announced it has recently entered into an exclusive license agreement with Diurnal Group plc, a specialty pharmaceutical company targeting patient needs in chronic endocrine diseases, for the registration and commercialization of Alkindi for pediatric adrenocortical insufficiency (AI) in Switzerland. Under the terms of the agreement EffRx has received the exclusive rights to register and commercialize Alkindi in Switzerland.

Alkindi is the first preparation of hydrocortisone specifically designed for use in children suffering from paediatric adrenocortical insufficiency (AI). Alkindi is a patented, oral, immediate-release paediatric formulation of hydrocortisone granules in capsules for opening that allows for accurate age-appropriate dosing in children. This therapeutic approach has the potential to help young patients less than eighteen years of age suffering from pediatric AI and the related condition congenital adrenal hyperplasia (CAH).

Alkindi is already approved and marketed in the European Union and is the first preparation of hydrocortisone specifically designed for use in children suffering from AI. On September 29th, 2020 the US Food and Drug Administration (FDA) has also approved Alkindi for AI.

EffRx has recently submitted to Swissmedic (Switzerland) a Market Authorization Application for the registration of Alkindi. Pending successful regulatory registration, this new treatment approach is expected to be available on the Swiss market by 2022. In Switzerland there are approximately 200 patients suffering from pediatric AI.

We are extremely pleased to announce this partnership with Diurnal which demonstrates EffRx capability to expand its portfolio with promising niche and orphan medicines, commented Lorenzo Bosisio, CEO of EffRx Pharmaceuticals. We look forward to bringing this novel therapeutic approach to Switzerland. We are confident that Alkindi provides a tangible advancement for young patients suffering from AI and their carers.

Martin Whitaker, CEO of Diurnal, commented: This partnership with EffRx further validates the quality of our products and broadens the future availability of Alkindi. EffRx is well-placed to register and market our product Alkindi in Switzerland. We have made strong progress with the sales of Alkindi across Europe since its approval and subsequent launch in 2018, and we are confident this agreement will enable further growth.

Pediatric AI, including the genetic condition CAH is a condition characterised by deficiency in cortisol, an essential hormone in regulating metabolism and the response to stress. The primary symptoms of AI are chronic fatigue and patients are at risk of adrenal crisis and death if they do not have adequate cortisol replacement. AI is either primary or secondary, with primary AI resulting from diseases intrinsic to the adrenal gland and secondary AI resulting from pituitary diseases where there is a failure of stimulation of the adrenal by the pituitary of the signalling hormone ACTH (adrenocorticotropic hormone).

About EffRx Pharmaceuticals

EffRx Pharmaceuticals is a commercial-stage pharmaceutical company focused on the late stage development and commercialization of prescription medications for niche and orphan indications. The business model is centered around providing superior clinical and commercial value propositions for physicians, payers and patients.

EffRx pro-actively seeks in-licensing opportunities for Europe in niche therapeutic areas, with a primary interest for rare diseases, where EffRx has received an orphan drug designation (ODD) from the FDA for a pipeline asset.

EffRxs go-to-market competence is proven by the development, launch and lucrative expansion of Binosto in a highly competitive European market. Our lead commercialized product, Binosto for the treatment of osteoporosis, is marketed in the US as well as selected European and Asian countries.

About Diurnal Group plc

Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing high quality products for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency and hypogonadism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena.

For further information about Diurnal, please visit http://www.diurnal.co.uk

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EffRx Pharmaceuticals Signs Exclusive License Agreement with Diurnal for the Registration and Commercialization of Alkindi and Submits Market...

Male Hypogonadism Therapy Market is Booming Worldwide By Top Key Players: Eli Lilly, Pfizer, AbbVie, Novo Nordisk, Merck KGaA, Mylan, Bayer, Teva,…

LOS ANGELES, United States: QY Research has recently published a research report titled, Global Male Hypogonadism Therapy Market Size, Status and Forecast 2020-2026. This report has been prepared by experienced and knowledgeable market analysts and researchers. It is a phenomenal compilation of important studies that explore the competitive landscape, segmentation, geographical expansion, and revenue, production, and consumption growth of the global Male Hypogonadism Therapy market. Players can use the accurate market facts and figures and statistical studies provided in the report to understand the current and future growth of the global Male Hypogonadism Therapy market.

The report includes CAGR, market shares, sales, gross margin, value, volume, and other vital market figures that give an exact picture of the growth of the global Male Hypogonadism Therapy market.

Competitive Landscape

Competitor analysis is one of the best sections of the report that compares the progress of leading players based on crucial parameters, including market share, new developments, global reach, local competition, price, and production. From the nature of competition to future changes in the vendor landscape, the report provides in-depth analysis of the competition in the global Male Hypogonadism Therapy market.

Key questions answered in the report:

TOC

Table of Contents 1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered: Ranking by Male Hypogonadism Therapy Revenue1.4 Market Analysis by Type1.4.1 Global Male Hypogonadism Therapy Market Size Growth Rate by Type: 2020 VS 20261.4.2 Parenteral1.4.3 Transdermal1.4.4 Oral1.4.5 Others1.5 Market by Application1.5.1 Global Male Hypogonadism Therapy Market Share by Application: 2020 VS 20261.5.2 Hospitals1.5.3 Drugstores1.5.4 Others1.6 Study Objectives1.7 Years Considered 2 Global Growth Trends by Regions2.1 Male Hypogonadism Therapy Market Perspective (2015-2026)2.2 Male Hypogonadism Therapy Growth Trends by Regions2.2.1 Male Hypogonadism Therapy Market Size by Regions: 2015 VS 2020 VS 20262.2.2 Male Hypogonadism Therapy Historic Market Share by Regions (2015-2020)2.2.3 Male Hypogonadism Therapy Forecasted Market Size by Regions (2021-2026)2.3 Industry Trends and Growth Strategy2.3.1 Market Top Trends2.3.2 Market Drivers2.3.3 Market Challenges2.3.4 Porters Five Forces Analysis2.3.5 Male Hypogonadism Therapy Market Growth Strategy2.3.6 Primary Interviews with Key Male Hypogonadism Therapy Players (Opinion Leaders) 3 Competition Landscape by Key Players3.1 Global Top Male Hypogonadism Therapy Players by Market Size3.1.1 Global Top Male Hypogonadism Therapy Players by Revenue (2015-2020)3.1.2 Global Male Hypogonadism Therapy Revenue Market Share by Players (2015-2020)3.1.3 Global Male Hypogonadism Therapy Market Share by Company Type (Tier 1, Tier 2 and Tier 3)3.2 Global Male Hypogonadism Therapy Market Concentration Ratio3.2.1 Global Male Hypogonadism Therapy Market Concentration Ratio (CR5 and HHI)3.2.2 Global Top 10 and Top 5 Companies by Male Hypogonadism Therapy Revenue in 20193.3 Male Hypogonadism Therapy Key Players Head office and Area Served3.4 Key Players Male Hypogonadism Therapy Product Solution and Service3.5 Date of Enter into Male Hypogonadism Therapy Market3.6 Mergers & Acquisitions, Expansion Plans 4 Breakdown Data by Type (2015-2026)4.1 Global Male Hypogonadism Therapy Historic Market Size by Type (2015-2020)4.2 Global Male Hypogonadism Therapy Forecasted Market Size by Type (2021-2026) 5 Male Hypogonadism Therapy Breakdown Data by Application (2015-2026)5.1 Global Male Hypogonadism Therapy Market Size by Application (2015-2020)5.2 Global Male Hypogonadism Therapy Forecasted Market Size by Application (2021-2026) 6 North America6.1 North America Male Hypogonadism Therapy Market Size (2015-2020)6.2 Male Hypogonadism Therapy Key Players in North America (2019-2020)6.3 North America Male Hypogonadism Therapy Market Size by Type (2015-2020)6.4 North America Male Hypogonadism Therapy Market Size by Application (2015-2020) 7 Europe7.1 Europe Male Hypogonadism Therapy Market Size (2015-2020)7.2 Male Hypogonadism Therapy Key Players in Europe (2019-2020)7.3 Europe Male Hypogonadism Therapy Market Size by Type (2015-2020)7.4 Europe Male Hypogonadism Therapy Market Size by Application (2015-2020) 8 China8.1 China Male Hypogonadism Therapy Market Size (2015-2020)8.2 Male Hypogonadism Therapy Key Players in China (2019-2020)8.3 China Male Hypogonadism Therapy Market Size by Type (2015-2020)8.4 China Male Hypogonadism Therapy Market Size by Application (2015-2020) 9 Japan9.1 Japan Male Hypogonadism Therapy Market Size (2015-2020)9.2 Male Hypogonadism Therapy Key Players in Japan (2019-2020)9.3 Japan Male Hypogonadism Therapy Market Size by Type (2015-2020)9.4 Japan Male Hypogonadism Therapy Market Size by Application (2015-2020) 10 Southeast Asia10.1 Southeast Asia Male Hypogonadism Therapy Market Size (2015-2020)10.2 Male Hypogonadism Therapy Key Players in Southeast Asia (2019-2020)10.3 Southeast Asia Male Hypogonadism Therapy Market Size by Type (2015-2020)10.4 Southeast Asia Male Hypogonadism Therapy Market Size by Application (2015-2020) 11 India11.1 India Male Hypogonadism Therapy Market Size (2015-2020)11.2 Male Hypogonadism Therapy Key Players in India (2019-2020)11.3 India Male Hypogonadism Therapy Market Size by Type (2015-2020)11.4 India Male Hypogonadism Therapy Market Size by Application (2015-2020) 12 Central & South America12.1 Central & South America Male Hypogonadism Therapy Market Size (2015-2020)12.2 Male Hypogonadism Therapy Key Players in Central & South America (2019-2020)12.3 Central & South America Male Hypogonadism Therapy Market Size by Type (2015-2020)12.4 Central & South America Male Hypogonadism Therapy Market Size by Application (2015-2020) 13 Key Players Profiles13.1 Eli Lilly13.1.1 Eli Lilly Company Details13.1.2 Eli Lilly Business Overview and Its Total Revenue13.1.3 Eli Lilly Male Hypogonadism Therapy Introduction13.1.4 Eli Lilly Revenue in Male Hypogonadism Therapy Business (2015-2020))13.1.5 Eli Lilly Recent Development13.2 Pfizer13.2.1 Pfizer Company Details13.2.2 Pfizer Business Overview and Its Total Revenue13.2.3 Pfizer Male Hypogonadism Therapy Introduction13.2.4 Pfizer Revenue in Male Hypogonadism Therapy Business (2015-2020)13.2.5 Pfizer Recent Development13.3 AbbVie13.3.1 AbbVie Company Details13.3.2 AbbVie Business Overview and Its Total Revenue13.3.3 AbbVie Male Hypogonadism Therapy Introduction13.3.4 AbbVie Revenue in Male Hypogonadism Therapy Business (2015-2020)13.3.5 AbbVie Recent Development13.4 Novo Nordisk13.4.1 Novo Nordisk Company Details13.4.2 Novo Nordisk Business Overview and Its Total Revenue13.4.3 Novo Nordisk Male Hypogonadism Therapy Introduction13.4.4 Novo Nordisk Revenue in Male Hypogonadism Therapy Business (2015-2020)13.4.5 Novo Nordisk Recent Development13.5 Merck KGaA13.5.1 Merck KGaA Company Details13.5.2 Merck KGaA Business Overview and Its Total Revenue13.5.3 Merck KGaA Male Hypogonadism Therapy Introduction13.5.4 Merck KGaA Revenue in Male Hypogonadism Therapy Business (2015-2020)13.5.5 Merck KGaA Recent Development13.6 Mylan13.6.1 Mylan Company Details13.6.2 Mylan Business Overview and Its Total Revenue13.6.3 Mylan Male Hypogonadism Therapy Introduction13.6.4 Mylan Revenue in Male Hypogonadism Therapy Business (2015-2020)13.6.5 Mylan Recent Development13.7 Bayer13.7.1 Bayer Company Details13.7.2 Bayer Business Overview and Its Total Revenue13.7.3 Bayer Male Hypogonadism Therapy Introduction13.7.4 Bayer Revenue in Male Hypogonadism Therapy Business (2015-2020)13.7.5 Bayer Recent Development13.8 Teva13.8.1 Teva Company Details13.8.2 Teva Business Overview and Its Total Revenue13.8.3 Teva Male Hypogonadism Therapy Introduction13.8.4 Teva Revenue in Male Hypogonadism Therapy Business (2015-2020)13.8.5 Teva Recent Development13.9 Novartis13.9.1 Novartis Company Details13.9.2 Novartis Business Overview and Its Total Revenue13.9.3 Novartis Male Hypogonadism Therapy Introduction13.9.4 Novartis Revenue in Male Hypogonadism Therapy Business (2015-2020)13.9.5 Novartis Recent Development13.10 Abbott13.10.1 Abbott Company Details13.10.2 Abbott Business Overview and Its Total Revenue13.10.3 Abbott Male Hypogonadism Therapy Introduction13.10.4 Abbott Revenue in Male Hypogonadism Therapy Business (2015-2020)13.10.5 Abbott Recent Development13.11 Roche10.11.1 Roche Company Details10.11.2 Roche Business Overview and Its Total Revenue10.11.3 Roche Male Hypogonadism Therapy Introduction10.11.4 Roche Revenue in Male Hypogonadism Therapy Business (2015-2020)10.11.5 Roche Recent Development13.12 Endo International10.12.1 Endo International Company Details10.12.2 Endo International Business Overview and Its Total Revenue10.12.3 Endo International Male Hypogonadism Therapy Introduction10.12.4 Endo International Revenue in Male Hypogonadism Therapy Business (2015-2020)10.12.5 Endo International Recent Development13.13 Ipsen10.13.1 Ipsen Company Details10.13.2 Ipsen Business Overview and Its Total Revenue10.13.3 Ipsen Male Hypogonadism Therapy Introduction10.13.4 Ipsen Revenue in Male Hypogonadism Therapy Business (2015-2020)10.13.5 Ipsen Recent Development13.14 ANI Pharmaceuticals10.14.1 ANI Pharmaceuticals Company Details10.14.2 ANI Pharmaceuticals Business Overview and Its Total Revenue10.14.3 ANI Pharmaceuticals Male Hypogonadism Therapy Introduction10.14.4 ANI Pharmaceuticals Revenue in Male Hypogonadism Therapy Business (2015-2020)10.14.5 ANI Pharmaceuticals Recent Development13.15 TherapeuticsMD10.15.1 TherapeuticsMD Company Details10.15.2 TherapeuticsMD Business Overview and Its Total Revenue10.15.3 TherapeuticsMD Male Hypogonadism Therapy Introduction10.15.4 TherapeuticsMD Revenue in Male Hypogonadism Therapy Business (2015-2020)10.15.5 TherapeuticsMD Recent Development 14 Analysts Viewpoints/Conclusions 15 Appendix15.1 Research Methodology15.1.1 Methodology/Research Approach15.1.2 Data Source15.2 Disclaimer15.3 Author Details

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Male Hypogonadism Therapy Market is Booming Worldwide By Top Key Players: Eli Lilly, Pfizer, AbbVie, Novo Nordisk, Merck KGaA, Mylan, Bayer, Teva,...

Hormone Replacement Therapy Market Size, Trends, Growth, Key Companies, Forecast by 2026|Eli Lilly, Pfizer, AbbVie – Weekly Wall

Los Angeles, United States QY Research offers an overarching research and analysis-based study on the global Hormone Replacement Therapy market, covering growth prospects, market development potential, profitability, supply and demand, and other important subjects. The report presented here comes out as a highly reliable source of information and data on the global Hormone Replacement Therapy market. The researchers and analysts who have prepared the report used an advanced research methodology and authentic primary and secondary sources of market information and data. Readers are provided with clear understanding on the current and future situations of the global Hormone Replacement Therapy market based on revenue, volume, production, trends, technology, innovation, and other critical factors.

Major Key Manufacturers of Hormone Replacement Therapy Market are: , Eli Lilly, Pfizer, AbbVie, Novo Nordisk, Merck KGaA, Mylan, Bayer, Teva, Novartis, Abbott, Roche, Endo International, Ipsen, ANI Pharmaceuticals, TherapeuticsMD

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The report offers an in-depth assessment of key market dynamics, the competitive landscape, segments, and regions in order to help readers to become better familiar with the global Hormone Replacement Therapy market. It particularly sheds light on market fluctuations, pricing structure, uncertainties, potential risks, and growth prospects to help players to plan effective strategies for gaining successful in the global Hormone Replacement Therapy market. Importantly, it allows players to gain deep insights into the business development and market growth of leading companies operating in the global Hormone Replacement Therapy market. Players will also be able to know about future market challenges, distribution scenarios, product pricing changes, and other related factors beforehand.

Global Hormone Replacement Therapy Market by Type Segments:

, Estrogen Hormone, Growth Hormone, Thyroid Hormone, Testosterone Hormone, The proportion of estrogen hormone in 2018 is about 50%, and the proportion is in increasing trend from 2014 to 2018.

Global Hormone Replacement Therapy Market by Application Segments:

, Menopause, Hypothyroidism, Growth Hormone Deficiency, Male Hypogonadism, Other Diseases, The most proportion of hormone replacement therapy is used in menopause, and the proportion in 2018 is 46.2%.

Table of Contents

Table of Contents 1 Report Overview1.1 Research Scope1.2 Top Hormone Replacement Therapy Manufacturers Covered: Ranking by Revenue1.3 Market Segment by Type1.3.1 Global Hormone Replacement Therapy Market Size by Type: 2015 VS 2020 VS 2026 (US$ Million)1.3.2 Estrogen Hormone1.3.3 Growth Hormone1.3.4 Thyroid Hormone1.3.5 Testosterone Hormone1.4 Market Segment by Application1.4.1 Global Hormone Replacement Therapy Consumption by Application: 2015 VS 2020 VS 20261.4.2 Menopause1.4.3 Hypothyroidism1.4.4 Growth Hormone Deficiency1.4.5 Male Hypogonadism1.4.6 Other Diseases1.5 Study Objectives1.6 Years Considered 2 Global Market Perspective2.1 Global Hormone Replacement Therapy Revenue (2015-2026)2.1.1 Global Hormone Replacement Therapy Revenue (2015-2026)2.1.2 Global Hormone Replacement Therapy Sales (2015-2026)2.2 Hormone Replacement Therapy Market Size across Key Geographies Worldwide: 2015 VS 2020 VS 20262.2.1 Global Hormone Replacement Therapy Sales by Regions (2015-2020)2.2.2 Global Hormone Replacement Therapy Revenue by Regions (2015-2020)2.3 Global Top Hormone Replacement Therapy Regions (Countries) Ranking by Market Size2.4 Hormone Replacement Therapy Industry Trends2.4.1 Hormone Replacement Therapy Market Top Trends2.4.2 Market Drivers2.4.3 Hormone Replacement Therapy Market Challenges 2.4.4 Porters Five Forces Analysis2.4.5 Primary Interviews with Key Hormone Replacement Therapy Players: Views for Future 3 Competitive Landscape by Manufacturers3.1 Global Top Hormone Replacement Therapy Manufacturers by Sales (2015-2020)3.1.1 Global Hormone Replacement Therapy Sales by Manufacturers (2015-2020)3.1.2 Global Hormone Replacement Therapy Sales Market Share by Manufacturers (2015-2020)3.1.3 Global 5 and 10 Largest Manufacturers by Hormone Replacement Therapy Sales in 20193.2 Global Top Manufacturers Hormone Replacement Therapy by Revenue3.2.1 Global Hormone Replacement Therapy Revenue by Manufacturers (2015-2020)3.2.2 Global Hormone Replacement Therapy Revenue Share by Manufacturers (2015-2020)3.2.3 Global Hormone Replacement Therapy Market Concentration Ratio (CR5 and HHI)3.3 Global Top Manufacturers by Company Type (Tier 1, Tier 2 and Tier 3) (based on the Revenue in Hormone Replacement Therapy as of 2019)3.4 Global Hormone Replacement Therapy Average Selling Price (ASP) by Manufacturers3.5 Key Manufacturers Hormone Replacement Therapy Plants/Factories Distribution and Area Served3.6 Date of Key Manufacturers Enter into Hormone Replacement Therapy Market3.7 Key Manufacturers Hormone Replacement Therapy Product Offered 3.8 Mergers & Acquisitions, Expansion Plans 4 Market Size by Type4.1 Global Hormone Replacement Therapy Historic Market Review by Type (2015-2020)4.1.2 Global Hormone Replacement Therapy Sales Market Share by Type (2015-2020)4.1.3 Global Hormone Replacement Therapy Revenue Market Share by Type (2015-2020)4.1.4 Hormone Replacement Therapy Price by Type (2015-2020)4.1 Global Hormone Replacement Therapy Market Estimates and Forecasts by Type (2021-2026)4.2.2 Global Hormone Replacement Therapy Sales Forecast by Type (2021-2026)4.2.3 Global Hormone Replacement Therapy Revenue Forecast by Type (2021-2026)4.2.4 Hormone Replacement Therapy Price Forecast by Type (2021-2026) 5 Global Hormone Replacement Therapy Market Size by Application5.1 Global Hormone Replacement Therapy Historic Market Review by Application (2015-2020)5.1.2 Global Hormone Replacement Therapy Sales Market Share by Application (2015-2020)5.1.3 Global Hormone Replacement Therapy Revenue Market Share by Application (2015-2020)5.1.4 Hormone Replacement Therapy Price by Application (2015-2020)5.2 Global Hormone Replacement Therapy Market Estimates and Forecasts by Application (2021-2026)5.2.2 Global Hormone Replacement Therapy Sales Forecast by Application (2021-2026)5.2.3 Global Hormone Replacement Therapy Revenue Forecast by Application (2021-2026)5.2.4 Hormone Replacement Therapy Price Forecast by Application (2021-2026) 6 North America6.1 North America Hormone Replacement Therapy Breakdown Data by Company6.2 North America Hormone Replacement Therapy Breakdown Data by Type6.3 North America Hormone Replacement Therapy Breakdown Data by Application6.4 North America Hormone Replacement Therapy Breakdown Data by Countries6.4.1 North America Hormone Replacement Therapy Sales by Countries6.4.2 North America Hormone Replacement Therapy Revenue by Countries6.4.3 U.S.6.4.4 Canada 7 Europe7.1 Europe Hormone Replacement Therapy Breakdown Data by Company7.2 Europe Hormone Replacement Therapy Breakdown Data by Type7.3 Europe Hormone Replacement Therapy Breakdown Data by Application7.4 Europe Hormone Replacement Therapy Breakdown Data by Countries7.4.1 Europe Hormone Replacement Therapy Sales by Countries7.4.2 Europe Hormone Replacement Therapy Revenue by Countries7.4.3 Germany7.4.4 France7.4.5 U.K.7.4.6 Italy7.4.7 Russia 8 Asia Pacific8.1 Asia Pacific Hormone Replacement Therapy Breakdown Data by Company8.2 Asia Pacific Hormone Replacement Therapy Breakdown Data by Type8.3 Asia Pacific Hormone Replacement Therapy Breakdown Data by Application8.4 Asia Pacific Hormone Replacement Therapy Breakdown Data by Regions8.4.1 Asia Pacific Hormone Replacement Therapy Sales by Regions8.4.2 Asia Pacific Hormone Replacement Therapy Revenue by Regions8.4.3 China8.4.4 Japan8.4.5 South Korea8.4.6 India8.4.7 Australia8.4.8 Taiwan8.4.9 Indonesia8.4.10 Thailand8.4.11 Malaysia8.4.12 Philippines8.4.13 Vietnam 9 Latin America9.1 Latin America Hormone Replacement Therapy Breakdown Data by Company9.2 Latin America Hormone Replacement Therapy Breakdown Data by Type9.3 Latin America Hormone Replacement Therapy Breakdown Data by Application9.4 Latin America Hormone Replacement Therapy Breakdown Data by Countries9.4.1 Latin America Hormone Replacement Therapy Sales by Countries9.4.2 Latin America Hormone Replacement Therapy Revenue by Countries9.4.3 Mexico9.4.4 Brazil9.4.5 Argentina 10 Middle East and Africa10.1 Middle East and Africa Hormone Replacement Therapy Breakdown Data by Type10.2 Middle East and Africa Hormone Replacement Therapy Breakdown Data by Application10.3 Middle East and Africa Hormone Replacement Therapy Breakdown Data by Countries10.3.1 Middle East and Africa Hormone Replacement Therapy Sales by Countries10.3.2 Middle East and Africa Hormone Replacement Therapy Revenue by Countries10.3.3 Turkey10.3.4 Saudi Arabia10.3.5 U.A.E 11 Company Profiles11.1 Eli Lilly11.1.1 Eli Lilly Corporation Information11.1.2 Eli Lilly Business Overview and Total Revenue (2019 VS 2018)11.1.3 Eli Lilly Hormone Replacement Therapy Sales, Revenue, Average Selling Price (ASP) and Gross Margin (2015-2020)11.1.4 Eli Lilly Hormone Replacement Therapy Products and Services11.1.5 Eli Lilly SWOT Analysis11.1.6 Eli Lilly Recent Developments11.2 Pfizer11.2.1 Pfizer Corporation Information11.2.2 Pfizer Business Overview and Total Revenue (2019 VS 2018)11.2.3 Pfizer Hormone Replacement Therapy Sales, Revenue, Average Selling Price (ASP) and Gross Margin (2015-2020)11.2.4 Pfizer Hormone Replacement Therapy Products and Services11.2.5 Pfizer SWOT Analysis11.2.6 Pfizer Recent Developments11.3 AbbVie11.3.1 AbbVie Corporation Information11.3.2 AbbVie Business Overview and Total Revenue (2019 VS 2018)11.3.3 AbbVie Hormone Replacement Therapy Sales, Revenue, Average Selling Price (ASP) and Gross Margin (2015-2020)11.3.4 AbbVie Hormone Replacement Therapy Products and Services11.3.5 AbbVie SWOT Analysis11.3.6 AbbVie Recent Developments11.4 Novo Nordisk11.4.1 Novo Nordisk Corporation Information11.4.2 Novo Nordisk Business Overview and Total Revenue (2019 VS 2018)11.4.3 Novo Nordisk Hormone Replacement Therapy Sales, Revenue, Average Selling Price (ASP) and Gross Margin (2015-2020)11.4.4 Novo Nordisk Hormone Replacement Therapy Products and Services11.4.5 Novo Nordisk SWOT Analysis11.4.6 Novo Nordisk Recent Developments11.5 Merck KGaA11.5.1 Merck KGaA Corporation Information11.5.2 Merck KGaA Business Overview and Total Revenue (2019 VS 2018)11.5.3 Merck KGaA Hormone Replacement Therapy Sales, Revenue, Average Selling Price (ASP) and Gross Margin (2015-2020)11.5.4 Merck KGaA Hormone Replacement Therapy Products and Services11.5.5 Merck KGaA SWOT Analysis11.5.6 Merck KGaA Recent Developments11.6 Mylan11.6.1 Mylan Corporation Information11.6.2 Mylan Business Overview and Total Revenue (2019 VS 2018)11.6.3 Mylan Hormone Replacement Therapy Sales, Revenue, Average Selling Price (ASP) and Gross Margin (2015-2020)11.6.4 Mylan Hormone Replacement Therapy Products and Services11.6.5 Mylan SWOT Analysis11.6.6 Mylan Recent Developments11.7 Bayer11.7.1 Bayer Corporation Information11.7.2 Bayer Business Overview and Total Revenue (2019 VS 2018)11.7.3 Bayer Hormone Replacement Therapy Sales, Revenue, Average Selling Price (ASP) and Gross Margin (2015-2020)11.7.4 Bayer Hormone Replacement Therapy Products and Services11.7.5 Bayer SWOT Analysis11.7.6 Bayer Recent Developments11.8 Teva11.8.1 Teva Corporation Information11.8.2 Teva Business Overview and Total Revenue (2019 VS 2018)11.8.3 Teva Hormone Replacement Therapy Sales, Revenue, Average Selling Price (ASP) and Gross Margin (2015-2020)11.8.4 Teva Hormone Replacement Therapy Products and Services11.8.5 Teva SWOT Analysis11.8.6 Teva Recent Developments11.9 Novartis11.9.1 Novartis Corporation Information11.9.2 Novartis Business Overview and Total Revenue (2019 VS 2018)11.9.3 Novartis Hormone Replacement Therapy Sales, Revenue, Average Selling Price (ASP) and Gross Margin (2015-2020)11.9.4 Novartis Hormone Replacement Therapy Products and Services11.9.5 Novartis SWOT Analysis11.9.6 Novartis Recent Developments11.10 Abbott11.10.1 Abbott Corporation Information11.10.2 Abbott Business Overview and Total Revenue (2019 VS 2018)11.10.3 Abbott Hormone Replacement Therapy Sales, Revenue, Average Selling Price (ASP) and Gross Margin (2015-2020)11.10.4 Abbott Hormone Replacement Therapy Products and Services11.10.5 Abbott SWOT Analysis11.10.6 Abbott Recent Developments11.11 Roche11.11.1 Roche Corporation Information11.11.2 Roche Business Overview and Total Revenue (2019 VS 2018)11.11.3 Roche Hormone Replacement Therapy Sales, Revenue, Average Selling Price (ASP) and Gross Margin (2015-2020)11.11.4 Roche Hormone Replacement Therapy Products and Services11.11.5 Roche SWOT Analysis11.11.6 Roche Recent Developments11.12 Endo International11.12.1 Endo International Corporation Information11.12.2 Endo International Business Overview and Total Revenue (2019 VS 2018)11.12.3 Endo International Hormone Replacement Therapy Sales, Revenue, Average Selling Price (ASP) and Gross Margin (2015-2020)11.12.4 Endo International Hormone Replacement Therapy Products and Services11.12.5 Endo International SWOT Analysis11.12.6 Endo International Recent Developments11.13 Ipsen11.13.1 Ipsen Corporation Information11.13.2 Ipsen Business Overview and Total Revenue (2019 VS 2018)11.13.3 Ipsen Hormone Replacement Therapy Sales, Revenue, Average Selling Price (ASP) and Gross Margin (2015-2020)11.13.4 Ipsen Hormone Replacement Therapy Products and Services11.13.5 Ipsen SWOT Analysis11.13.6 Ipsen Recent Developments11.14 ANI Pharmaceuticals11.14.1 ANI Pharmaceuticals Corporation Information11.14.2 ANI Pharmaceuticals Business Overview and Total Revenue (2019 VS 2018)11.14.3 ANI Pharmaceuticals Hormone Replacement Therapy Sales, Revenue, Average Selling Price (ASP) and Gross Margin (2015-2020)11.14.4 ANI Pharmaceuticals Hormone Replacement Therapy Products and Services11.14.5 ANI Pharmaceuticals SWOT Analysis11.14.6 ANI Pharmaceuticals Recent Developments11.15 TherapeuticsMD11.15.1 TherapeuticsMD Corporation Information11.15.2 TherapeuticsMD Business Overview and Total Revenue (2019 VS 2018)11.15.3 TherapeuticsMD Hormone Replacement Therapy Sales, Revenue, Average Selling Price (ASP) and Gross Margin (2015-2020)11.15.4 TherapeuticsMD Hormone Replacement Therapy Products and Services11.15.5 TherapeuticsMD SWOT Analysis11.15.6 TherapeuticsMD Recent Developments 12 Supply Chain and Sales Channels Analysis 12.1 Supply Chain Analysis 12.2 Sales Channels Analysis12.2.1 Hormone Replacement Therapy Sales Channels12.2.2 Hormone Replacement Therapy Distributors12.3 Hormone Replacement Therapy Customers 13 Estimates and Projections by Regions (2021-2026)13.1 Global Hormone Replacement Therapy Sales Forecast (2021-2026)13.1.1 Global Hormone Replacement Therapy Sales Forecast by Regions (2021-2026)13.1.2 Global Hormone Replacement Therapy Revenue Forecast by Regions (2021-2026) 13.2 North America Market Size Forecast (2021-2026)13.2.1 North America Hormone Replacement Therapy Sales Forecast (2021-2026)13.2.2 North America Hormone Replacement Therapy Revenue Forecast (2021-2026)13.2.3 North America Hormone Replacement Therapy Size Forecast by County (2021-2026) 13.3 Europe Market Size Forecast (2021-2026)13.3.1 Europe Hormone Replacement Therapy Sales Forecast (2021-2026)13.3.2 Europe Hormone Replacement Therapy Revenue Forecast (2021-2026)13.3.3 Europe Hormone Replacement Therapy Size Forecast by County (2021-2026) 13.4 Asia Pacific Market Size Forecast (2021-2026)13.4.1 Asia Pacific Hormone Replacement Therapy Sales Forecast (2021-2026)13.4.2 Asia Pacific Hormone Replacement Therapy Revenue Forecast (2021-2026)13.4.3 Asia Pacific Hormone Replacement Therapy Size Forecast by Region (2021-2026) 13.5 Latin America Market Size Forecast (2021-2026)13.5.1 Latin America Hormone Replacement Therapy Sales Forecast (2021-2026)13.5.2 Latin America Hormone Replacement Therapy Revenue Forecast (2021-2026)13.5.3 Latin America Hormone Replacement Therapy Size Forecast by County (2021-2026) 13.6 Middle East and Africa Market Forecast13.6.1 Middle East and Africa Hormone Replacement Therapy Sales Forecast (2021-2026)13.6.2 Middle East and Africa Hormone Replacement Therapy Revenue Forecast (2021-2026)13.6.3 Middle East and Africa Hormone Replacement Therapy Size Forecast by County (2021-2026) 14 Research Findings and Conclusion 15 Appendix15.1 Research Methodology15.1.1 Methodology/Research Approach15.1.2 Data Source15.2 Author Details15.3 Disclaimer

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Hormone Replacement Therapy Market Size, Trends, Growth, Key Companies, Forecast by 2026|Eli Lilly, Pfizer, AbbVie - Weekly Wall

Aytu BioScience Announces Fiscal Q4 2020 Net Revenue of $14.9 Million, an Increase of 82% Sequentially, and 766% Year-Over-Year – BioSpace

ENGLEWOOD, CO / ACCESSWIRE / October 6, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs today reported financial results for its fiscal fourth quarter 2020, for the three month period ending June 30, 2020.

Fourth Quarter Fiscal 2020 Financial Highlights

Commenting on the fourth quarter of fiscal 2020, Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated "Revenue increased exponentially in Q4 2020, to $14.9 million, compared to $1.7 million for Q4 2019. It is important to note that this was the first full quarter of revenue from the combined Aytu and Innovus businesses, along with the Cerecor assets. Turning to the bottom line, adjusted EBITDA loss was reduced to just $1.7 million for Q4 2020, compared to a $3.7 million adjusted EBITDA loss for Q4 2019. On the balance sheet, with approximately $48.3 million in cash, cash equivalents and restricted cash after paying $15 million to fully extinguish the Deerfield balloon payment previously due January 2021, we have less than $1 million of debt, and at current spending levels, we believe we have sufficient runway to reach profitability."

Mr. Disbrow continued, "Taking a closer look at the top line, both of our revenue streams, from the Consumer Health and Rx segments, performed well. On the Consumer Health side, we generated $6.9 million in revenue, an increase compared to Q3. Contributing to those results was organic growth within our core Consumer Health product lines of diabetes care, sexual wellness and bladder health. Additionally, we strengthened our e-commerce business for Consumer Health. Furthermore, our newly launched Consumer Health product, Regoxidine, an over-the-counter foam formulation of minoxidil for hair regrowth, is on track to contribute revenue in excess of seven figures in its first twelve months from launch."

Mr. Disbrow added, "On the Rx side, revenue was $7.9 million, a significant increase compared to Q3. Contributing to Rx revenue was solid contribution from the pediatric franchise. Additional value was created with Natesto gaining preferred status on Express Scripts' national formulary and the Natesto spermatogenesis study results published in the Journal of Urology, both of which we expect to drive prescription growth in the coming quarters. Organic Rx growth was fueled by a relatively balanced contribution across our key products and improved sales execution. Despite the impact COVID has had on physician office access, Q4 represented a record revenue quarter for our Rx business and significant growth over the previous quarters. This is a strong statement about our field execution and clinical value of our products, and I'm pleased to see our call levels now picking back up to near normal in the current quarter to further drive prescription growth."

Mr. Disbrow concluded, "At $14.9 million in record quarterly revenue, with a narrowed Adjusted EBITDA loss, $48.3 million of cash, cash equivalents and restricted cash on the balance sheet, the addition of the Healight opportunity for COVID-19 and future potential non-COVID-19 applications, and our addition to the Russell 2000, we have strong momentum to grow shareholder value in fiscal 2021 and onward."

Conference Call Information

The company will host a live conference call at 4:30 p.m. ET today. The conference call can be accessed by dialing either:

877-407-9124 (toll-free)

201-689-8584 (international)

The webcast will be accessible live at https://www.webcaster4.com/Webcast/Page/2142/37506 and archived on Aytu BioScience's website, within the Investors section under Events & Presentations, at aytubio.com, for 90 days.

A replay of the call will be available for fourteen days. Access the replay by calling 1-877-481-4010 (toll-free) or 919-882-2331 (international) and using the replay access code 37506.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The recently acquired Pediatric Portfolio includes (i) Cefaclor, a second-generation cephalosporin antibiotic suspension; (ii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iii) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid test. This antibody test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. Aytu has also licensed the Healight Platform Technology. Healight is a pre-clinical investigational device being studied as a potential treatment for COVID-19 in severely ill, intubated patients and potentially other respiratory illnesses.

Aytu also operates a consumer health subsidiary, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company licensing, developing, and commercializing safe and effective consumer healthcare products designed to improve health and vitality. Innovus commercializes over twenty consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, our ability to successfully commercialize Healight Platform Technology, our ability to obtain FDA approval for the Healight Platform Technology, the effectiveness of the Healight Platform Technology in treating patients with COVID-19 or other illnesses, our ability to adequately protect the intellectual property associated with the Healight Platform Technology, regulatory delays, the reliability of the Healight Platform Technology in killing viruses and bacteria, market acceptance of UV based medical devices, the regulatory and commercial risks associated with introducing the COVID-19 rapid tests, any delays in shipment that may impact our ability to distribute the COVID-19 rapid tests, any reputational harm we may incur if there are delays in receiving the shipment of the COVID-19 rapid tests, our ability to enforce the exclusivity provisions of the distribution agreements, the reliability of serological testing in detecting COVID-19, shipping delays and their impact on our ability to introduce the COVID-19 rapid tests, the ability of the COVID-19 rapid tests to accurately and reliably test for COVID-19, the manufacturers of the COVID-19 rapid tests' ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 rapid tests, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 rapid test kits, the demand or lack thereof for the COVID-19 rapid test kits, our ability to obtain additional COVID-19 rapid tests to meet demand, our ability to secure additional tests if the manufacturers of the COVID-19 rapid tests are unable to meet demand, the effects of the business combination of Aytu and the Pediatric Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Pediatric Portfolio, the ultimate timing, outcome and results of integrating the operations the Pediatric Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

Non-GAAP Financial Information

This press release contains a financial measure that does not comply with U.S. generally accepted accounting principles (GAAP), Non-GAAP Adjusted EBITDA. Non-GAAP Adjusted EBITDA excludes (i) amortization, (ii) depreciation, (iii) stock-based compensation, (iv) other expenses comprising net interest expense, (v) non-cash gains and/or losses recognized in the quarter or year due to changes in the fair value of certain of Aytu's financial liabilities, such as contingent consideration, derivative warrant liability, or certain exchanges of debt, (vi) bad debt expense, (vii) impairment of certain long-lived assets; (viii) one-time transaction costs and (ix) costs associated with the Company's Healight technology. Management believes these measures are useful to supplement its GAAP financial statements with this non-GAAP information because management uses such information internally for its operating, budgeting and financial planning purposes. In addition, Aytu believes these non-GAAP financial measures are useful to investors because they allow for greater transparency into the indicators used by management as a basis for its financial and operational decision making. Non-GAAP information is not prepared under a comprehensive set of accounting rules and therefore, should only be read in conjunction with financial information reported under U.S. GAAP when understanding Aytu's operating performance. A reconciliation between GAAP and non-GAAP financial information is provided in the financial statement tables below.

AYTU BIOSCIENCE, INC. AND SUBSIDIARIESConsolidated Statements of Operations

(Unaudited)

Three Months Ended June 30,

Revenues

Product revenue, net

License revenue, net

Total product revenue

Operating expenses

Cost of sales

Research and development

Selling, general and administrative

Selling, general and administrative - related party

Impairment of intangible assets

Amortization of intangible assets

Total operating expenses

Loss from operations

Other (expense) income

Other (expense), net

(Loss) / gain from change in fair value of contingent consideration

(Loss) on extinguishment of debt

Gain from warrant derivative liability

Total other (expense) income

Net loss

Weighted average number of shares outstanding ofcommon shares outstanding

Basic and diluted net loss per common share

AYTU BIOSCIENCE, INC. AND SUBSIDIARIESConsolidated Balance Sheets

Assets

Current assets

Cash and cash equivalents

Restricted cash

Accounts receivable, net

Inventory, net

Prepaid expenses and other

Other current assets

Total current assets

Fixed assets, net

Right-of-use asset

Licensed assets, net

Patents and tradenames, net

Product technology rights, net

Deposits

Goodwill

Total long-term assets

Total assets

AYTU BIOSCIENCE, INC. AND SUBSIDIARIESConsolidated Balance Sheets, Cont'd

Liabilities

Current liabilities

Accounts payable and other

Accrued liabilities

Accrued compensation

Debt

Contract liability

Current lease liability

Current portion of fixed payment arrangements

Current portion of CVR liabilities

Current portion of contingent consideration

Total current liabilities

Long-term contingent consideration, net of current portion

Long-term lease liability, net of current portion

Long-term fixed payment arrangements, net of current portion

Long-term CVR liabilities, net of current portion

Warrant derivative liability

Total liabilities

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Aytu BioScience Announces Fiscal Q4 2020 Net Revenue of $14.9 Million, an Increase of 82% Sequentially, and 766% Year-Over-Year - BioSpace

Aytu BioScience to Report Fourth Quarter and Full Year Fiscal 2020 Results and Provide Business Update on Tuesday, October 6, 2020 – Yahoo Finance

Live Conference Call and Webcast at 4:30 PM ET

ENGLEWOOD, CO / ACCESSWIRE / October 5, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU) (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced today that the Company will present its operational results for the fiscal fourth quarter and year ended June 30, 2020 on October 6, 2020, at 4:30 p.m. ET. The Company will review accomplishments from the quarter and fiscal year and provide an overview of its business and growth strategy.

The Company will file Form 10-K after the markets close on October 6, 2020.

Conference Call Information

1-877-407-9124 (toll-free)1-201-689-8584 (international)

The webcast will be accessible live and archived at the following link, https://www.webcaster4.com/Webcast/Page/2142/37506 and on Aytu BioScience's website, within the Investors section under Events & Presentations, at aytubio.com, for 90 days.

A replay of the call will be available for fourteen days. Access the replay by calling 1-877-481-4010 (toll-free) or 919-882-2331 (international) and using the replay access code 37506.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid antibody test and rapid antigen tests. These assays are used in the rapid, qualitative diagnostic assessment of the 2019 Novel Coronavirus. Additionally, Aytu recently licensed worldwide rights to develop the Healight technology platform. Healight is an investigational medical device being studied as a prospective treatment for COVID-19 and other respiratory infections.

Story continues

Aytu also operates a consumer health subsidiary, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the regulatory and commercial risks associated with introducing the COVID-19 rapid tests, the accuracy of the COVID-19 rapid tests as compared to other COVID-19 tests, market acceptance of the tests, the ability to obtain FDA approval or authorization for the tests, our ability to obtain sufficient tests to meet consumer demand, if any, the manufacturers' ability to scale up manufacturing to meet customer demand, if any, reputation risks if the tests are not as effective as anticipated, and that the current regulatory environment continues to permit the sale of the tests. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/608913/Aytu-BioScience-to-Report-Fourth-Quarter-and-Full-Year-Fiscal-2020-Results-and-Provide-Business-Update-on-Tuesday-October-6-2020

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Aytu BioScience to Report Fourth Quarter and Full Year Fiscal 2020 Results and Provide Business Update on Tuesday, October 6, 2020 - Yahoo Finance

Sperm Take Up to 3 Years to Recover After Anabolic Steroids – Medscape

Contrary to prior understanding, many hormones related to spermatogenesis take longer to recover than previously thought, and up to 3 years in some cases after anabolic steroid misuse, according to a fertility expert speaking at the Royal Society of Medicine webinar series.

Dr Channa Jayasena, consultant in reproductive endocrinology and andrology at Imperial College and Hammersmith Hospital, London, gave a talk on male hypogonadism that he admitted might seem provocative to some people but addresses issues that extend current knowledge. The three key issues discussed were: how quickly can men recover fertility after androgen use; how to assist azoospermic men with Klinefelter syndrome (or XXY) father children; and whether testosterone therapy affects progression to diabetes in obese men.

Dr Jayasena spoke at last weeks 3-day webinar held by the Royal Society of Medicine, Endocrinology and Diabetes section, entitled, EDN50:What's new in endocrinology and diabetes 2020?

He began by asking how quicky do men who take anabolic steroids recover fertility? "This has never been studied to much extent."

Self-confessed steroid user and reality television star, Spencer Matthews, said in a tabloid newspaper article that the UK is in the grips of an epidemic of anabolic steroid use, Dr Jayasena remarked. "I see men who take anabolic steroids but then they want a baby and want to know whats next?"

The nearest data to understanding recovery from anabolic steroids comes from studies of the male pill, said the andrologist. This involves giving a high level of progesterone to suppress luteinising hormone and follicle stimulating hormone (in effect the male pill), and then giving the men testosterone replacement. A Lancet paper (Liu at al 2006) involving this regimen looked at the time from stopping the male pill to recovery of sperm. It shows that, by 12 months, all participants had recovered some sperm function, with 80% recovering to the pre-treatment semen level, explained Dr Jayasena. "This has long been presumed to be the measure of recovery. However, this does not resonate with reality and the observation that actually there are many people who dont recover within this time frame and take a lot longer, some with azoospermia[semen containing no sperm]," he pointed out.

Another cross-sectional observational study looked at 41 current users of anabolic steroids, 31 recent ( 3 months since last use), and 21 healthy eugonadal men. All were 18-55 years, exercising at least three times a week. "The critical strength of this study is that these men were all clinically indistinct," Dr Jayasena remarked. "This matching of baseline characteristics is critical for interpretation of the data. Due to recruitment issues, weve never had such a good look at recovery in this way before."

The study looked at the reproductive endocrine profiles including the levels of luteinising hormone, follicle stimulating hormone, and testosterone. In current users, the former two were suppressed and the testosterone level was high, as expected, displaying a hypogonadatropic profile. "Past users and non-users have very similar profiles, suggesting reversible luteinising hormone and follicle stimulating hormone suppression," said Dr Jayasena, adding, "this is really interesting and looking at acne, gynaecomastia, hair loss and smaller testicles all classical features of androgen abuse - appear to persist in many of the men who are past users. Its important we counsel these men that we, the clinicians, are not really clear about how long these side effects will persist."

Results also showed low HDL cholesterol and high triglycerides in users, but not in non-users or past users, and cardiac hypertrophy in users but not past users. "The latter finding is encouraging," Dr Jayasena pointed out.

Regarding fertility, the study by Shankara-Naranya found that when comparing non-users to users of anabolic steroids, it took a mean of 10.7 months for users to recover their luteinising hormone levels to the mean luteinising hormone of a non-user. "But recovery time is highly variable. Luteinising hormone (and testosterone by inference), and sperm concentration seem to recover within a year, with a mean of 10 months, but all the other hormones that are important for spermatogenesis take much longer to recover so follicle stimulating hormone was 20 months, inhibin B was 32 months, sperm motility was 38 months, up to 3 years to recover. This is critical and we didnt know this," reported Dr Jaysena.

"In answer to what is the prognosis for recovery in men after androgen misuse? The endocrine system mostly recovers in the first year but sperm take much longer to recover," he concluded.

Along with Downs syndrome, Klinefelter is the most common chromosomal disorder in men, affecting 1 in 500 men. A total of 90% of those with Klinefelter syndrome are azoospermic, and it has long been assumed to be incompatible with fatherhood.

"Things have changed, and Id like to ask what is the chance of fatherhood for a man with XXY undergoing microdissection testicular sperm extraction (mTESE)?" said Dr Jayasena. "This can be done by dissecting open a testicle and looking for an engorged seminiferous tubule that is likely to be full of sperm," he explained. "If this is confirmed, after some processing, the sperm can be used in intracytoplasmicsperm injection (ICSI)."

It has been known that it was possible for patients with Klinefelter syndrome to father children for the past 20 years, but, asked Dr Jayasena, how successful is it? "Its still an embryonic field," he noted. Referring to a meta-analysis of 37 studies, Dr Jayasena said 40% of men with Klinefelters syndrome had sperm retrieved, and of these 40%, an average of nearly 50% of men had live births after ICSI. But some studies reported 10% and others 90%.

In conclusion, the chances of fatherhood in XXY men undergoing mTESE, is around 20% but a large randomised controlled trial (RCT) is needed to confirm this, said Dr Jayasena.

Finally, the researcher moved on to the third topic of whether testosterone therapy improves the effectiveness of weight loss in men over 50 years with type 2 diabetes. Referring to outcomes of the largest, as yet unpublished, testosterone trial ever, in more than 1000 men by Dr Gary Wittert, from the University of Adelaide, Dr Jayasena described the study.

Most importantly, they did not select men with hypogonadism these results are not valid for hypogonadism because not all men had hypogonadism, explained Dr Jayasena. Two-hour plasma glucose was 7.8 to 15 mmol/l. The men were randomised to Weight Watchers weight loss programme plus placebo versus the same weight loss programme plus testosterone. They also excluded men with high cardiovascular risk, due to a Food and Drug Administration [FDA] unproven concern about cardiovascular risk. "Testosterone may be dangerous in some of these men (59-75 years and obese) in real life," he pointed out.

The paper is currently in review but some preliminary findings were presented at a conference earlier this year. Dr Jayasena says: "If testosterone improves the prevention of type 2 diabetes during weight loss in men without hypogonadism, then that would challenge our understanding of how it works. However, testosterone is still not a treatment to prevent type 2 diabetes,"

To answer the question definitively, said Dr Jayasena, confirmatory data, mechanistic data, and safety data are needed.

COI: Dr Jayasena received an honorarium for speaking during a debate organised by the Society for Endocrinology and sponsored by Besins Healthcare. He has an investigator-led grant by Logixx Pharma Ltd.

Presented at the Royal Society of Medicine, Endocrinology and Diabetes section, entitled, EDN50: What's new in endocrinology and diabetes 2020? , Day 3. September 23, 2020

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Sperm Take Up to 3 Years to Recover After Anabolic Steroids - Medscape

Covid-19 could lower testosterone levels and libido in men – heres what the new study found – Shields Gazette

Covid-19 could lower testosterone levels and libido in men - heres what the new study found(Photo: Shutterstock)

A new study has revealed that men who contracted Covid-19 have their testosterone levels lowered by 30 per cent, on average.

Even two thirds of men who showed no symptoms reported a loss of libido.

Researchers in Turkey analysed levels of sex hormone in 232 men who were hospitalised after they tested positive for Covid-19.

What is hypogonadism?

More than half (51 per cent) of the men had developed a condition called hypogonadism, meaning their bodies did not produce enough testosterone.

On average participants levels were drained by 30 per cent post-infection, to borderline unhealthy levels.

Academics from the University of Mersin who ran the study claim there is a direct correlation between severe illness and lower testosterone levels.

Lead author, Professor Selahittin ayan (a urologist at the university) said, In our study, the mean total testosterone decreased, as the severity of the Covid-19 increased.

The mean total testosterone level was significantly lower in the ICU group than in the asymptomatic group.

In addition, the mean total testosterone level was significantly lower in the ICU group than in the standard care group.

Why do men need testosterone?

Testosterone is key to the development of sex organs and muscle growth. The hormone also helps regulate the bodys immune responses, including fighting off viral infections.

Low levels have been linked to an increased risk of dying from the flu, as well as inflammation, heart disease and high blood pressure.

A healthy level of testosterone is usually considered to be above 300 nanograms per decilitre (ng/dl).

Results in the study showed that patients saw their levels drop by a third, on average, from 458 ng/dl to 315 ng/dl.

Professor ayan describes the uses of the hormone saying, Testosterone is associated with the immune system of respiratory organs, and low levels of testosterone might increase the risk of respiratory infections.

Low testosterone is also associated with infection-related hospitalisation and all-cause mortality in male in ICU patients, so testosterone treatment may also have benefits beyond improving outcomes for Covid-19.

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Covid-19 could lower testosterone levels and libido in men - heres what the new study found - Shields Gazette

Testosterone Replacement Therapy Market 2020 Global Industry Sales, Industry Analysis with Top Countries Data, Share, Trends, Market Demand, Revenue,…

Global Testosterone Replacement Therapy Market Research Report provides primary Data, surveys, Scope of the Product and vendor briefing. The market dynamic forces have been determined after conducting a detailed study of the Global Testosterone Replacement Therapy market. It also provides key analysis on the market status of the Testosterone Replacement Therapy manufacturers with best facts and figures, meaning, definition, SWOT analysis, expert opinions and the latest developments across the globe. The Report also calculate the market size, Testosterone Replacement Therapy Sales, Price, Revenue, Gross Margin and Market Share, cost structure and growth rate. The report considers the revenue generated from the sales of This Report and technologies by various application segments.

COVID-19 can affect the global economy in three main ways: by directly affecting production and demand, by creating supply chain and market disruption, and by its financial impact on firms and financial markets.

Final Report will add the analysis of the impact of COVID-19 on this industry.

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Short Description About Testosterone Replacement Therapy Market:

Testosterone replacement therapy (TRT) is a class of hormone replacement therapy in which androgens, often testosterone, are replaced. Testosterone replacement therapy (TRT) is an FDA-approved medical treatment for men of any age who have low testosterone, a hormone necessary for male sexual development.

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The research covers the current Testosterone Replacement Therapy market size of the market and its growth rates based on 5-year records with company outline ofKey players/manufacturers:

Scope of the Testosterone Replacement Therapy Market Report:This report focuses on the Testosterone Replacement Therapy in global market, especially in North America, Europe and Asia-Pacific, South America, Middle East and Africa. This report categorizes the market based on manufacturers, regions, type and application.Testosterone deficiency, also referred to as hypogonadism, is a common problem among men aged between 40 and 79 years, with some studies stating that nearly 30% of all men worldwide are affected by hypogonadism. As the incidence of testosterone deficiency increases, it is expected that the demand for TRT will also show a simultaneous increase.The global average price of testosterone replacement therapy is in the decreasing trend, from 45.4 USD/Unit in 2012 to 34.9 USD/Unit in 2016. With the situation of global economy, prices will be in decreasing trend in the following five years.The classification of testosterone replacement therapy includes gels, injections, patches and other types, and the proportion of gels in 2016 is about 72%.Testosterone replacement therapy is widely sold in hospitals, clinics and other field. The most proportion of testosterone replacement therapy is sold in clinics, and the consumption proportion is about 43%.North America region is the largest supplier of testosterone replacement therapy, with a production market share nearly 86% in 2016. Europe is the second largest supplier of Testosterone Replacement Therapy, enjoying production market share nearly 9.9% in 2016.North America is the largest consumption place, with a consumption market share nearly 83% in 2016. Following North America, Europe is the second largest consumption place with the consumption market share of 12%. Market competition is intense. AbbVie, Endo International, Eli Lilly, Pfizer, Actavis (Allergan)Bayer, etc. are the leaders of the industry. The top five players together held about 80% of the market in the same year and they hold key technologies and patents, with high-end customers; have been formed in the monopoly position in the industry. The worldwide market for Testosterone Replacement Therapy is expected to grow at a CAGR of roughly -4.2% over the next five years, will reach 1410 million US$ in 2023, from 1820 million US$ in 2020, According to a New Research study.

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Report further studies the market development status and future Testosterone Replacement Therapy Market trend across the world. Also, it splits Testosterone Replacement Therapy market Segmentation by Type and by Applications to fully and deeply research and reveal market profile and prospects.

Major Classifications are as follows:

Major Applications are as follows:

Geographically,this report is segmented into severalkey regions, with sales, revenue, market share and growth Rate of Testosterone Replacement Therapy in these regions, from 2014 to 2024, covering

This Testosterone Replacement Therapy Market Research/Analysis Report Contains Answers to your following Questions

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Major Points from Table of Contents:

1. Market Overview1.1 Testosterone Replacement Therapy Introduction1.2 Market Analysis by Type1.3 Market Analysis by Applications1.4 Market Dynamics1.4.1 Market Opportunities1.4.2 Market Risk1.4.3 Market Driving Force

2.Manufacturers Profiles

2.4.1 Business Overview2.4.2 Testosterone Replacement Therapy Type and Applications2.4.2.1 Product A2.4.2.2 Product B

3.Global Testosterone Replacement Therapy Sales, Revenue, Market Share and Competition By Manufacturer (2019-2020)

3.1 Global Testosterone Replacement Therapy Sales and Market Share by Manufacturer (2019-2020)3.2 Global Testosterone Replacement Therapy Revenue and Market Share by Manufacturer (2019-2020)3.3 Market Concentration Rates3.3.1 Top 3 Testosterone Replacement Therapy Manufacturer Market Share in 20203.3.2 Top 6 Testosterone Replacement Therapy Manufacturer Market Share in 20203.4 Market Competition Trend

4.Global Testosterone Replacement Therapy Market Analysis by Regions

4.1 Global Testosterone Replacement Therapy Sales, Revenue and Market Share by Regions4.1.1 Global Testosterone Replacement Therapy Sales and Market Share by Regions (2014-2019)4.1.2 Global Testosterone Replacement Therapy Revenue and Market Share by Regions (2014-2019)4.2 North America Testosterone Replacement Therapy Sales and Growth Rate (2014-2019)4.3 Europe Testosterone Replacement Therapy Sales and Growth Rate (2014-2019)4.4 Asia-Pacific Testosterone Replacement Therapy Sales and Growth Rate (2014-2019)4.6 South America Testosterone Replacement Therapy Sales and Growth Rate (2014-2019)4.6 Middle East and Africa Testosterone Replacement Therapy Sales and Growth Rate (2014-2019)

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5.Testosterone Replacement Therapy Market Forecast (2020-2024)5.1 Global Testosterone Replacement Therapy Sales, Revenue and Growth Rate (2020-2024)5.2 Testosterone Replacement Therapy Market Forecast by Regions (2020-2024)5.3 Testosterone Replacement Therapy Market Forecast by Type (2020-2024)5.3.1 Global Testosterone Replacement Therapy Sales Forecast by Type (2020-2024)5.3.2 Global Testosterone Replacement Therapy Market Share Forecast by Type (2020-2024)5.4 Testosterone Replacement Therapy Market Forecast by Application (2020-2024)5.4.1 Global Testosterone Replacement Therapy Sales Forecast by Application (2020-2024)5.4.2 Global Testosterone Replacement Therapy Market Share Forecast by Application (2020-2024)

6.Sales Channel, Distributors, Traders and Dealers6.1 Sales Channel6.1.1 Direct Marketing6.1.2 Indirect Marketing6.1.3 Marketing Channel Future Trend6.2 Distributors, Traders and Dealers

7.Research Findings and Conclusion

8.Appendix8.1 Methodology8.2 Data Source

Continued..

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Testosterone Replacement Therapy Market 2020 Global Industry Sales, Industry Analysis with Top Countries Data, Share, Trends, Market Demand, Revenue,...

Treatment of the infertile couple – Contemporary Obgyn

This is the second part of a 2-part Infertility series. Read Part 1: The diagnosis of the infertile couple

Infertility treatment begins with shared decision-making with the couple. Besides the usual risks, benefits, and alternatives, the couples desire for a biologic child, their resources, and their insurance coverage will govern subsequent therapy.

Accurate diagnosis from a basic infertility evaluation often results in an easy therapeutic recommendation.

Based on their diagnosis, a couple may be offered a variety of treatments: often simple, sometimes very complex. Genetic testing of couples or their embryos will also provide additional opportunities in family building. Donor gametes, donor embryos, and adoption are often the most cost-effective route to having a child.

Clomiphene citrate is a synthetic estrogen receptor modulator. By blocking the estrogen receptor at the level of the hypothalamus and pituitary, the negative feedback of estrogen is eschewed and gonadotropin-releasing hormone (GNRH) pulses increase follicle-stimulating hormone (FSH) and luteinizing hormone (LH) production.1

These elevated gonadotropins stimulate early follicle development, increase estradiol production, and mature the oocyte. Clomiphene is most often administered as a daily oral dose for 5 days in the early follicular phase (eg, beginning between day 3 and day 5 of the menstrual cycle), beginning at 50 mg/day.

Clomiphene citrate causes FSH and LH to rise; after discontinuation, gonadotropins fall and allow the normal estrogen feedback of a developing follicle to return. Thus, when the oocyte is mature, an LH surge is triggered by the ovary, or an exogenous human chorionic gonadotropin hormone (HcG) trigger can be administered, and ovulation ensues.

Adverse effects (AEs) of clomiphene citrate include hot flashes, thickened cervical mucus, vaginal dryness, scotomata, pelvic heaviness, and headaches.1 Hyperstimulation of the ovaries is rare. Because clomiphene citrate may cause thickened cervical mucus, it is often used in combination with intrauterine insemination, especially in treatment of unexplained infertility.2

Aromatase inhibitors act in a similar fashion to clomiphene citrate, although by a different mechanism.

These medications block aromatase, the enzyme which converts androgens to estrogens; estrogen is decreased to menopausal levels. The low concentration of estrogen results in increased GNRH pulses and stimulates gonadotropin release from the pituitary.

Aromatase inhibitors are given orally, starting at 2.5 mg per day from day 3 to 8 of the cycle. AEs include hot flashes, vaginal dryness, nausea, muscle aches, and headaches. Data from meta-analyses, registry studies, and retrospective cohort studies do not appear to suggest increased risk of birth defects with either clomiphene citrate or letrozole.3-10

Patients treated with clomiphene citrate or aromatase inhibitors may use an ovulation predictor kit to measure the LH surge and time their intercourse accordingly. Ovulation occurs an average of 7 days after discontinuation of clomiphene citrate and approximately 34 to 40 hours after detection of the LH surge.

Thus, patients may start testing their urine with an ovulation predictor kit on day 11 of their cycle and have intercourse on the day of the surge and the day after. Both clomiphene citrate and aromatase inhibitors have a multiple pregnancy rate of less than 10%, the majority of which are twin pregnancies,11 compared with 3% of the general population.

Gonadotropins (LH and FSH) directly stimulate the ovarian follicles and have been used in the treatment of anovulation related to eugonadotropic hypogonadism (eg, polycystic ovary syndrome), when clomiphene citrate or aromatase inhibitors fail, as well as for women with hypogonadotropic hypogonadism who will typically not respond to clomiphene or letrozole.

Estrogen concentrations are stimulated to much higher than physiologic concentrations and thus inhibit the natural ovulatory LH surge; thus, the LH surge must be exogenously administered and is done so by treating with HcG, which has LH activity.

Gonadotropin administration should be performed only under the supervision of a reproductive endocrinologist. Administration must be monitored by frequent estradiol measurement and ultrasonography of the ovaries.12 Multiple pregnancy rates can be in excess of 25% per cycle with 3% to 5% higher-order multiple pregnancy rates.

Another serious consequence of gonadotropin treatment is ovarian hyperstimulation syndrome (OHSS), resulting in ascites, pleural effusion, hyponatremia, pulmonary edema,13,14 and vascular depletion, with the resultant hemoconcentration leading to decreased renal perfusion and pulmonary embolism.

In light of the high multiple pregnancy rate as well as the need for stringent monitoring and cycle cancellation,5 gonadotropin therapy for anovulation related to eugonadotropic hypogonadism is generally discouraged.

It is important to note that once a patient is ovulating, she has the same chance of conceiving that fertile patients of similar age have, unless another infertility factor is present.

Therefore, after 4 to 6 ovulatory cycles without pregnancy in an anovulatory patient, the patient should be evaluated for other causes of infertility, if a workup has not already been completed.15

Intrauterine insemination (IUI) is used in the treatment of mild male factor infertility, cervical factor infertility, and, along with ovarian stimulation, in the treatment of unexplained infertility. This requires serial dilution of the ejaculate,16 centrifugation, and reconstitution with media.

The washed, concentrated sperm is placed into the uterus with a catheter 24 to 36 hours after an endogenous LH surge or the exogenous ovulation trigger. The sperm will be waiting in the Fallopian tube to fertilize the oocyte after ovulation.

For unexplained infertility in the absence of male factor, IUI alone does not increase pregnancy rates over expectant management; therefore, IUI should be utilized in combination with OS in these instances.17

If severe male factor infertility exists (eg, less than 4 million total sperm, or the strict morphology reveals less than 4% normal forms), the pregnancy rate with in vitro fertilization (IVF) is higher than with IUI.18

Ovarian stimulation (OS) may be used to treat unexplained infertility, male factor infertility, or hypogonadotropic hypogonadism, and may be performed with clomiphene citrate, aromatase inhibitors, or gonadotropins. The premise of OS is to allow for 2 or 3 oocytes to be ovulated and increase the statistical change of conception that might occur in any 1 cycle.

Pregnancy rates with OS depend on the diagnosis, choice of therapy, sperm viability, and ovarian response. OS in combination with IUI is largely used in the treatment of unexplained infertility or male factor infertility; particularly for unexplained infertility, neither clomiphene nor letrozole is more effective than expectant management when combined with timed intercourse alone.17 Pregnancy rates with OS-IUI depend on the diagnosis, sperm viability, and ovarian response.

With respect to OS with gonadotropins, the Fast Track and Standard Treatment Trial randomized women aged less than 40 years with unexplained infertility to treatment with clomiphene-IUI followed, if unsuccessful, by (1) gonadotropins-IUI or (2) IVF; results showed that the time to pregnancy was significantly shorter in the clomiphene to IVF group.19

Therefore, in most cases, it is generally recommended that unsuccessful trials of OS with oral medications be followed by IVF rather than gonadotropins. Additionally, multiple pregnancies, as well as OHSS, represent serious consequences of OS with gonadotropins, and their use to treat unexplained infertility is not recommended.17

Infertile women may be at an increased risk of invasive ovarian, endometrial, and breast cancer, but fertility drugs do not appear to increase this risk significantly.20,21

Small cohort studies suggest that infertility medications may increase theriskof borderline ovarian cancer slightly in infertile women treated with infertility drugs, but the absolute risk is small. However, it appears that this risk does not occur unless clomiphene is given for an extended time, and it has not been shown with aromatase inhibitors.22

In vitro fertilization (IVF) initially used for the treatment of tubal factor infertility in 1978, has been extended to treat a variety of causes of infertility; IVF is also used by noninfertile individuals pursuing fertility preservation.

Indeed, IVF allows women without oocytes or a uterus and men without sperm in the ejaculate to have a biological child. IVF is indicated in cases of severe oligospermia or azoospermia, untreated tubal factor, or infertility in women 40 years and older, and it may also be utilized in women with endometriosis, anovulation, or unexplained infertility when ovulation induction and IUI have been unsuccessful. IVF is also utilized when genetic screening of embryos is planned.

IVF protocols vary depending on the indication, patient age, treatment history, and other considerations.

A typical IVF cycle involves, first, ovulation induction to stimulate multiple ovarian follicles, followed by oocyte aspiration using a transvaginal ultrasound-guided needle. Collected oocytes are fertilized in vitroby mixing them with spermatozoa (IVF) or by injecting selected spermatozoa directly into the oocyte cytoplasm (intracytoplasmic sperm injection).

Embryos are cultured under carefully controlled conditions, optimizing oxygen concentration, embryo culture media, and other modifications to promote the development of high-quality embryos.

The embryos are then transferred into the uterus through a catheter under ultrasound guidance. In the case of severe male factor infertility, sperm retrieval from the epididymis or testis may also be performed. Embryos not transferred may be cryopreserved to transfer in a later cycle (frozen embryo transfer).

Preimplantation genetic testing (PGT) is a procedure in which cultured embryos can be biopsied and tested in order to select the most appropriate embryos for transfer.

Prior to transfer, PGT can be used to screen for euploid embryos for transfer (PGT-aneuploid [PGT-A]); however, specific groups of infertility patients most likely to benefit from PGT-A have not been clearly defined. PGT may also be utilized to identify embryos with a single gene disorder (PGT-monogenic or preimplantation genetic diagnosis); this would be used, for example, if both partners are carriers for the same autosomal recessive condition, such as cystic fibrosis.

Donor gametes may be considered when either partner has severe defects in gamete quality or quantity. For males, such situations may include severe oligospermia, azoospermia, failure of fertilization in prior IVF cycles, ejaculatory dysfunction, or other severe male factor infertility (ie, after gonadotoxic chemotherapy).

Donor oocytes or embryos may be used when a womans oocyte reserve is low (ie, advanced reproductive age or diminished ovarian reserve) or oocyte quality is poor, when multiple attempts at IVF with her own oocytes have failed, or when a condition such as premature ovarian insufficiency makes the likelihood of conceiving with her own gametes extremely low.

Donor gametes may also be utilized when either partner has a significant genetic defect, or if there is a family history of a genetic condition for which carrier status cannot be determined.

Females without male partners, same-sex couples, or males without female partners may also utilize donor gametes, either anonymously from donor gamete banks or known donors.23

A gestational carrier (GC) is defined as a woman who carries a pregnancy and is not sexually intimate with the genetic parents or gamete donors.24

A GC may be used when a medical condition prevents a woman from carrying a pregnancy or when she has a congenital or surgical absence of a uterus. A GC may also be indicated if a pregnancy would pose significant risk to a womans health or life, or if there is a biological inability to carry a pregnancy, as with single males or gay male couples.

Lastly, uterine transplant is an emerging option for individuals without a uterus; it is currently available only in the setting of clinical research trials.25

Although legal adoption has allowed couples to build a family for more than a century, modern technology now allows for effective therapy for infertility in many cases, guided by accurate diagnosis and shared decision-making.

The basic evaluation of an infertile couple has been supplemented with an evaluation of related health issues, as our knowledge has advanced to include surveillance beyond the reproductive system (Table).

The primary care practitioner is vital in not only initiating the evaluation, surveying for related health problems, and referring to specialty care, but also longitudinally, following patients for possible disease processes harbingered by infertility.

__

About the Authors

DR. KALLEN is an assistant professor of Obstetrics, Gynecology, and Reproductive Sciences in the Division of Reproductive Endocrinology and Infertility within the Department of Obstetrics, Gynecology, and Reproductive Sciences at Yale School of Medicine, Yale University.

DR. CARSON is a professor of Obstetrics, Gynecology, and Reproductive Sciences in the Division Chief, Division of Reproductive Endocrinology and Infertility within the Department of Obstetrics, Gynecology, and Reproductive Sciences at Yale School of Medicine, Yale University.

__

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Treatment of the infertile couple - Contemporary Obgyn

Testosterone boosters: Uses and effectiveness – Medical News Today

Testosterone boosters include medications and supplements designed to increase testosterone levels in the body. While low testosterone can trigger a range of symptoms, increasing this hormone comes with risks.

In this article, we discuss different types of testosterone boosters and their effectiveness.

Testosterone is an androgen hormone that promotes the development of characteristics people typically associate with masculinity, such as facial hair, deep voice, and muscle growth.

Although testosterone is the principal male sex hormone, it is also present in females, though at much lower levels.

Testosterone influences various aspects of the human body, including:

The normal testosterone value in people varies due to many factors, such as age. The American Urological Association defines low testosterone as less than 300 nanograms per deciliter (ng/dL).

A 2017 study suggests the normal total testosterone range for males aged 1939 years is 264916 ng/dL. The research considers values higher than this as abnormally high.

Low testosterone, or hypogonadism, can occur due to an underlying medical condition, taking certain medications, or injuries to the testes. People may also experience high testosterone levels, typically due to anabolic steroid use, tumors on the adrenal glands, or a medical condition.

A testosterone booster, or testosterone supplement, refers to any natural or artificially produced substance that raises testosterone levels. These may include:

TRT, or androgen replacement therapy, is a medical treatment for low testosterone. It works by replacing the testosterone that the body is not producing. TRT may include:

Injectable testosterone, such as testosterone cypionate (Depo-Testosterone) and testosterone undecanoate (Aveed), contain testosterone esters suspended in oil. Esters are a type of biological compound.

A person can administer this form of testosterone by injecting the solution into the buttocks. People can take these injections every 24 weeks, depending on recommendations from doctors.

Transdermal testosterone includes medicated patches (Androderm) and gels (AndroGel) that people apply directly to the skin.

Androderm patches come in four different strengths: 2 mg, 2.5 mg, 4 mg, or 5 mg of testosterone. The recommended starting dose is one 4 mg patch every 24 hours. A person should apply this to clean, dry skin on the back, thighs, abdomen, or upper arms.

Testosterone gel is available at 1% and 1.62% concentrations. When starting the 1% formulation, a person should apply 50 mg once a day in the morning. The dosage can vary depending on their hormone levels.

Jatenzo is an oral testosterone capsule recently approved by the Food and Drug Administration (FDA) for treating hypogonadism due to underlying medical conditions. The FDA does not recommend Jatenzo for treating age-related low testosterone due to an increased risk of cardiovascular events.

Jatenzo is available in three strengths: 158 mg, 198 mg, and 237 mg. The manufacturers recommend that people start by taking 237 mg twice daily for 1 week. In clinical trials, 87% of participants achieved testosterone levels in the normal range at the end of treatment.

After the first week, a doctor can adjust the dosage according to a persons serum testosterone levels. People should also note that due to a potential increase in blood pressure, Jatenzo may increase the risk of cardiovascular events.

Some supplements may help increase the level of testosterone a persons body produces. These may include:

D-aspartic acid (DAA) is an amino acid that plays a role in creating and releasing several different hormones, including testosterone.

DAA acts on the hypothalamus, triggering an increase of gonadotropin-releasing hormone (GnRH). When GnRH is present, the pituitary gland releases luteinizing hormone (LH), which promotes testosterone production.

Dehydroepiandrosterone (DHEA) is a steroid hormone produced by the adrenal glands. It is a precursor hormone with minimal effects until the body converts it into other hormones, such as estrogen or testosterone.

Due to its effects, DHEA is a popular ingredient in testosterone-boosting supplements.

There are several reasons why a person might use testosterone boosters. These include:

Multiple factors can influence testosterone levels. The body naturally produces less of the hormone with age. In one 2016 study, researchers evaluated the levels of testosterone and DHEA of 271 healthy males between the ages of 4070.

The researchers found testosterone levels decreased by 1.28%, and DHEA decreased by 3.52% each year.

The following factors can lead to low testosterone levels:

TRT is effective in treating low testosterone, but it does not always address the underlying cause. A doctor may recommend lifestyle changes and other medication to treat hypogonadism due to overweight, metabolic disorders, or thyroid problems.

In a 2018 study, researchers coordinated seven controlled trials in 788 older males with low testosterone levels. The participants received either AndroGel 1% or a placebo for 12 months.

The results suggest that testosterone treatment led to moderate improvements in sexual function, bone density, and red blood cell count. Those in the testosterone treatment group showed mild improvements in walking distance, mood, and depressive symptoms.

In a 2017 article, researchers evaluated the efficacy of d-aspartic acid (DAA) reported in 27 animal and human studies.

Findings from the animal studies suggest that DAA increases testosterone levels. However, the human trials produced mixed results. This may be due to limitations of the study design, as well as differences in age, physical fitness levels, and the participants base testosterone levels.

A 2015 study researching the effects of DAA supplementation in 24 males with at least two years of resistance training suggests this technique either showed no significant changes or reduced testosterone levels based on the dosage.

The authors of a 2013 review examined findings from 25 randomized controlled trials that looked at the effects of DHEA supplementation in 1,353 men. The authors conclude it led to minor reductions in body fat, but no improvements in testosterone.

A 2018 review also states there is limited evidence to suggest that DHEA supplementation increases testosterone levels.

Testosterone boosters may provide the following benefits to people with low testosterone levels:

While testosterone replacement may help alleviate the symptoms of hypogonadism, it may not produce the same effects in people with naturally declining testosterone levels.

TRT may lead to the following side effects:

People who inject testosterone may experience pain, swelling, or bruising near the injection site. Topical testosterone gels and patches can also induce allergic reactions at the application site.

The American Urological Association only recommend TRT if a persons testosterone level is below 300 ng/dL, and they show symptoms of hypogonadism. However, the risks of TRT may outweigh its potential benefits.

The FDA does not regulate testosterone supplements, meaning that supplements vary widely in quality, purity, and dosage.

According to the FDA, there is a link between some bodybuilding supplements, as well as products marketed as testosterone alternatives, and the following adverse effects:

Testosterone boosters can help increase a persons testosterone levels. However, their effectiveness will vary based on the type of booster and a persons reasons for taking them.

Testosterone therapy appears to benefit people with conditions such as hypogonadism. However, TRT is usually not recommended to treat age-related declines in testosterone unless managing sexual dysfunction.

More research is necessary to support the use of alternative therapies, such as testosterone supplements. Supplements may also carry some risk of cardiovascular, kidney, and liver disease.

People should always consult a doctor before they start a new medication or supplement.

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Testosterone boosters: Uses and effectiveness - Medical News Today

Aytu BioScience to Report Fourth Quarter FY 2020 Results and Business Update on Thursday, September 24, 2020 – Yahoo Finance

Live Conference Call and Webcast at 4:30 ET

ENGLEWOOD, CO / ACCESSWIRE / September 16, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU) (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced today that the Company will present its operational results for the fiscal fourth quarter ended June 30, 2020 on September 24, 2020, at 4:30 p.m. ET. The Company will review accomplishments from the quarter and provide an overview of its business and growth strategy.

Conference Call Information

1-877-407-9124 (toll-free)1-201-689-8584 (international)

The webcast will be accessible live and archived at the following link, https://www.webcaster4.com/Webcast/Page/2142/37506 and on Aytu BioScience's website, within the Investors section under Events & Presentations, at aytubio.com, for 90 days.

A replay of the call will be available for fourteen days. Access the replay by calling 1-877-481-4010 (toll-free) or 919-882-2331 (international) and using the replay access code 37506.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid antibody test and rapid antigen tests. These assays are used in the rapid, qualitative diagnostic assessment of the 2019 Novel Coronavirus. Additionally, Aytu recently licensed worldwide rights to develop the Healight technology platform from Cedars-Sinai Medical Center. Healight is a pre-clinical medical device being studied as a prospective treatment for COVID-19 and other respiratory infections.

Aytu also operates a consumer health subsidiary, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the regulatory and commercial risks associated with introducing the COVID-19 rapid tests, the accuracy of the COVID-19 rapid tests as compared to other COVID-19 tests, market acceptance of the tests, the ability to obtain FDA approval or authorization for the tests, our ability to obtain sufficient tests to meet consumer demand, if any, the manufacturers' ability to scale up manufacturing to meet customer demand, if any, reputation risks if the tests are not as effective as anticipated, and that the current regulatory environment continues to permit the sale of the tests. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

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Aytu BioScience to Report Fourth Quarter FY 2020 Results and Business Update on Thursday, September 24, 2020 - Yahoo Finance

H.C. Wainwright Reiterated Lipocine Inc. [LPCN]. What else is Wall St. saying? – The DBT News

Lipocine Inc. [NASDAQ: LPCN] stock went on a downward path that fall over -5.41% on Tuesday, amounting to a one-week price decrease of less than -2.78%. The company report on August 28, 2020 that Lipocine Provides Regulatory Update for TLANDO.

Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it needs additional time to complete its review of TLANDOs New Drug Application (NDA) and is committed to taking action as expeditiously as possible. The anticipated Prescription Drug User Food Act (PDUFA) goal date was August 28, 2020 for TLANDO. Although the FDA did not provide a timeline on a new action date, the FDA informed the Company that the review is expected to be completed in the coming weeks. The FDA has not asked for any additional data and the Company has provided the FDA with all information requested to date.

TLANDO is the Companys oral testosterone product candidate for testosterone replacement therapy (TRT) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

Over the last 12 months, LPCN stock dropped by -55.70%. The average equity rating for LPCN stock is currently 2.50, trading closer to a bullish pattern in the stock market.

The market cap for the stock reached $91.98 million, with 65.69 million shares outstanding and 63.81 million shares in the current float. Compared to the average trading volume of 3.98M shares, LPCN stock reached a trading volume of 3277408 in the most recent trading day, which is why market watchdogs consider the stock to be active.

H.C. Wainwright have made an estimate for Lipocine Inc. shares, keeping their opinion on the stock as Buy, with their previous recommendation back on January 12, 2018. While these analysts kept the previous recommendation, Canaccord Genuity raised their target price from $11 to $2. The new note on the price target was released on January 11, 2018, representing the official price target for Lipocine Inc. stock. Previously, the target price had yet another raise to $10, while H.C. Wainwright analysts kept a Buy rating on LPCN stock.

The Average True Range (ATR) for Lipocine Inc. is set at 0.20, with the Price to Sales ratio for LPCN stock in the period of the last 12 months amounting to 459.90. The Price to Book ratio for the last quarter was 5.38, with the Price to Cash per share for the same quarter was set at 0.28.

Lipocine Inc. [LPCN] fell into the red zone at the end of the last week, falling into a negative trend and dropping by -2.78. With this latest performance, LPCN shares dropped by -18.13% in over the last four-week period, additionally plugging by 142.21% over the last 6 months not to mention a drop of -55.70% in the past year of trading.

Overbought and oversold stocks can be easily traced with the Relative Strength Index (RSI), where an RSI result of over 70 would be overbought, and any rate below 30 would indicate oversold conditions. An RSI rate of 50 would represent a neutral market momentum. The current RSI for LPCN stock in for the last two-week period is set at 38.05, with the RSI for the last a single of trading hit 33.01, and the three-weeks RSI is set at 43.43 for Lipocine Inc. [LPCN]. The present Moving Average for the last 50 days of trading for this stock 1.5779, while it was recorded at 1.5920 for the last single week of trading, and 0.8038 for the last 200 days.

Operating Margin for any stock indicates how profitable investing would be, and Lipocine Inc. [LPCN] shares currently have an operating margin of -7818.83. Lipocine Inc.s Net Margin is presently recorded at -7883.72.

Return on Total Capital for LPCN is now -77.88, given the latest momentum, and Return on Invested Capital for the company is -98.31. Return on Equity for this stock declined to -165.47, with Return on Assets sitting at -64.22. When it comes to the capital structure of this company, Lipocine Inc. [LPCN] has a Total Debt to Total Equity ratio set at 113.68. Additionally, LPCN Total Debt to Total Capital is recorded at 53.20, with Total Debt to Total Assets ending up at 36.36. Long-Term Debt to Equity for the company is recorded at 60.66, with the Long-Term Debt to Total Capital now at 28.39.

Reflecting on the efficiency of the workforce at the company, Lipocine Inc. [LPCN] managed to generate an average of -$1,083,945 per employee. Receivables Turnover for the company is 6.00 with a Total Asset Turnover recorded at a value of 0.01.Lipocine Inc.s liquidity data is similarly interesting compelling, with a Quick Ratio of 5.50 and a Current Ratio set at 5.50.

With the latest financial reports released by the company, Lipocine Inc. posted -0.12/share EPS, while the average EPS was predicted by analysts to be reported at -0.16/share. When compared, the two values demonstrate that the company surpassed the estimates by a Surprise Factor of 25.00%. The progress of the company may be observed through the prism of EPS growth rate, while Wall Street analysts are focusing on predicting the 5-year EPS growth rate for LPCN.

There are presently around $6 million, or 6.60% of LPCN stock, in the hands of institutional investors. The top three institutional holders of LPCN stocks are: VANGUARD GROUP INC with ownership of 1,104,304, which is approximately 3.554% of the companys market cap and around 1.10% of the total institutional ownership; AMERIPRISE FINANCIAL INC, holding 788,500 shares of the stock with an approximate value of $1.1 million in LPCN stocks shares; and BLACKROCK INC., currently with $1.01 million in LPCN stock with ownership of nearly -10.223% of the companys market capitalization.

Positions in Lipocine Inc. stocks held by institutional investors increased at the end of August and at the time of the August reporting period, where 20 institutional holders increased their position in Lipocine Inc. [NASDAQ:LPCN] by around 836,911 shares. Additionally, 9 investors decreased positions by around 171,052 shares, while 12 investors held positions by with 3,319,043 shares. The mentioned changes placed institutional holdings at 4,327,006 shares, according to the latest SEC report filing. LPCN stock had 11 new institutional investments in for a total of 550,302 shares, while 6 institutional investors sold positions of 84,899 shares during the same period.

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H.C. Wainwright Reiterated Lipocine Inc. [LPCN]. What else is Wall St. saying? - The DBT News

Hormone Replacement Therapy Market Research Provides an In-Depth Analysis on the Future Growth Prospects and Industry Trends Adopted by the…

A research report on the Hormone Replacement Therapy Market 2020 Industry Research Report is being published by Stats and Reports. This is a key document as far as the clients and industries are concerned to not only understand the competitive market status that exists currently but also what future holds for it in the upcoming period, i.e., between 2020 and 2026. It has taken the previous market status of 2013 2018 to project the future status. The report has categorized in terms of region, type, key industries, and application.

Major Geographical Regions

The study report on Global Hormone Replacement Therapy Market 2020 would cover every big geographical, as well as, sub-regions throughout the world. The report has focused on market size, value, product sales and opportunities for growth in these regions. The market study has analyzed the competitive trend apart from offering valuable insights to clients and industries. These data will undoubtedly help them to plan their strategy so that they could not only expand but also penetrate into a market.

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Acknowledge the Global Hormone Replacement Therapy market with the assist of our expert analyst moderating the worldwide fluctuations. This market report will answer all your queries regarding growth of your business in this Covid-19 pandemic.

The researchers have analyzed the competitive advantages of those involved in the industries or in the Hormone Replacement Therapy industry. While historical years were taken as 2013 2018, the base year for the study was 2018. Similarly, the report has given its projection for the year 2020 apart from the outlook for years 2020 2026.

Top Leading Companies and Type

Like any other research material, the report has covered key geographical regions such as Europe, Japan, United States, India, Southeast Asia and Europe. Researchers have given their opinion or insights of value, product sales, and industry share besides availability opportunities to expand in those regions. As far as the sub-regions, North America, Canada, Medico, Australia, Asia-Pacific, India, South Korea, China, Singapore, Indonesia, Japan, Rest of Asia-Pacific, Germany, United Kingdom, France, Spain, Italy, Rest of Europe, Russia, Central & South America, Middle East & Africa are included.

Major players in the report included are F. Hoffmann-La Roche, Novartis, Novo Nordisk, Amgen, ANI Pharmaceuticals, Bayer, Eli Lilly, Hisamitsu Pharmaceutical, Ipsen, Merck, Mylan Laboratories, Orion, QuatRx Pharmaceuticals, Teva Pharmaceutical Industries, TherapeuticsMD.

Types covered in the Hormone Replacement Therapy industry are Estrogen Replacement Therapy, Growth Hormone Replacement Therapy.

Applications covered in the report are Menopause, Hypothyroidism, Male Hypogonadism, Growth Hormone Deficiency.

As a part of our Corporate Social Responsibility, we would like to announce that we would be contributing 15 % of our profits to USA, UK, Italy, Spain and India relief fund.

Geographical Scope of this report includes:

Report Aims

The objective of the researchers is to find out the sales, value, and status of the Hormone Replacement Therapy industry at the international levels. While the status covers the years of 2013 2018, the forecast is for the period 2020 2026 that will enable market players to not only plan but also execute strategies based on the market needs.

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Hormone Replacement Therapy Market

The study wanted to focus on key manufacturers, competitive landscape, and SWOT analysis for the Hormone Replacement Therapy industry. Apart from looking into the geographical regions, the report concentrated on key trends and segments that are either driving or preventing the growth of the industry. Researchers have also focused on individual growth trends besides their contribution to the overall market.

Target Audience of the Global Hormone Replacement Therapy Market in Market Study:

Key Consulting Companies & AdvisersLarge, medium-sized, and small enterprisesVenture capitalistsValue-Added Re-sellers (VARs)Third-party knowledge providersInvestment bankersInvestors

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** The market is evaluated based on the weighted average selling price (WASP) and includes the taxes applicable to the manufacturer. All currency conversions used in the creation of this report were calculated using a certain annual average rate of 2020 currency conversion.

Crucial points encompassed in the report:

In the end, Hormone Replacement Therapy Market Report delivers a conclusion that includes Breakdown and Data Triangulation, Consumer Needs/Customer Preference Change, Research Findings, Market Size Estimation, Data Source. These factors will increase the business overall.

Major queries related Global Hormone Replacement Therapy Market with covid-19 effect resolves in the report:

1. How market players are performing in this covid-19 event?2. How the pricing of essential raw material and related market affects Hormone Replacement Therapy market.3. Is covid-19 pandemic already affected on projected region or what will be the maximum impact of covid-19 in region?4. What will be the CAGR growth of the Hormone Replacement Therapy market during the forecast period?5. In 2026 what will be the estimated value of Hormone Replacement Therapy market?

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Hormone Replacement Therapy Market Research Provides an In-Depth Analysis on the Future Growth Prospects and Industry Trends Adopted by the...

Male Hypogonadism Market Estimated to be Driven by Innovation and Industrialization 2017 2026 – The News Brok

Male Hypogonadism Market A synopsis

The Male Hypogonadism Market study presents a compilation of market share, demand analysis, and future outlook associated with each segment as well as sub-segment. The key segments include, product type, end use, region, and relevant competitors. Important product-wise segments covered in the report contain product 1, product 2, product 3, and product 4, while important end uses include end use 1, end use 2, end use 3, and end use 4.

The Male Hypogonadism Market is estimated to reach ~US$ xx Mn/Bn in 2019. With a CAGR of xx% throughout the historic period 2014-2019, the Male Hypogonadism Market is expected to grow at healthy CAGR of xx% over the foreseeable timeframe 2017 2026. In this research study, 2018 is considered as the base year.

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The Male Hypogonadism Market research provides vital insights to the readers:

The Male Hypogonadism Market research gets rid of the following queries:

The Male Hypogonadism Market research is a result of a comprehensive primary and secondary research performed by the analysts to extract the nuts and bolts of the Male Hypogonadism Market. Various service providers, implementation vendors and research in different departments of all gamut of companies were approached to provide a clear-cut picture of the market structure. Further, DROT analysis and Porters Five Forces analysis are used to offer the factors influencing the growth of the Male Hypogonadism Market.

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Male Hypogonadism Market Estimated to be Driven by Innovation and Industrialization 2017 2026 - The News Brok

Male Hypogonadism Therapy Industry 2020 Market Size, Share, Price, Trend And Forecast To 2026- Industry Growth Insights – The Scarlet

An analysis report published by IndustryGrowthInsights (IGI) is an in-depth study and detailed information regarding the market size, market performance and market dynamics of the Male Hypogonadism Therapy. The report offers a robust assessment of the Global Male Hypogonadism Therapy Market to understand the current trend of the market and deduces the expected market trend for the Male Hypogonadism Therapy market for the forecast period. Providing a concrete assessment of the potential impact of the ongoing COVID-19 in the next coming years, the report covers key strategies and plans prepared by the major players to ensure their presence intact in the global competition. With the availability of this comprehensive report, the clients can easily make an informed decision about their business investments in the market.

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This detailed report also highlights key insights on the factors that drive the growth of the market as well key challenges that are expected to hamper the market growth in the forecast period. Keeping a view to provide a holistic market view, the report describes the market components such as product types and end users in details with explaining which component is expected to expand significantly and which region is emerging as the key potential destination of the Male Hypogonadism Therapy market. Moreover, it provides a critical assessment of the emerging competitive landscape of the manufacturers as the demand for the Male Hypogonadism Therapy is projected to increase substantially across the different regions.

The report, published by IndustryGrowthInsights (IGI), is the most reliable information because it consists of a concrete research methodology focusing on primary as well as secondary sources. The report is prepared by relying on primary source including interviews of the company executives and representatives and accessing official documents, websites, and press release of the companies. The IndustryGrowthInsights (IGI)s report is widely known for its accuracy and factual figures as it consists of a concise graphical representations, tables, and figures which displays a clear picture of the developments of the products and its market performance over the last few years.

Furthermore, the scope of the growth potential, revenue growth, product range, and pricing factors related to the Male Hypogonadism Therapy market are thoroughly assessed in the report in a view to entail a broader picture of the market.

Key companies that are covered in this report:

Eli LillyPfizerAbbVieNovo NordiskMerck KGaAMylanBayerTevaNovartisAbbottRocheEndo InternationalIpsenANI PharmaceuticalsTherapeuticsMDMale Hypogonadism Therap

*Note: Additional companies can be included on request

The report covers a detailed performance of some of the key players and analysis of major players in the industry, segments, application and regions. Moreover, the report also takes into account the governments policies in the evaluation of the market behavior to illustrate the potential opportunities and challenges of the market in each region. The report also covers the recent agreements including merger and acquisition, partnership or joint venture and latest developments of the manufacturers to sustain in the global competition of the Male Hypogonadism Therapy market.

By Application:

HospitalsDrugstoresOthers

By Type:

ParenteralTransdermalOralOthersMale Hypogonadism Therap

You can also go for a yearly subscription of all the updates on Male Hypogonadism Therapy market.

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According to the report, the Male Hypogonadism Therapy market is projected to reach a value of USDXX by the end of 2026 and grow at a CAGR of XX% through the forecast period (2020-2026). The report covers the performance of the Male Hypogonadism Therapy in regions, North America, Latin America, Europe, Asia Pacific, and Middle East & Africa by focusing some key countries in the respective regions. As per the clients requirements, this report can be customized and available in a separate report for the specific region and countries.

The following is the TOC of the report:

Executive Summary

Assumptions and Acronyms Used

Research Methodology

Male Hypogonadism Therapy Market Overview

Global Male Hypogonadism Therapy Market Analysis and Forecast by Type

Global Male Hypogonadism Therapy Market Analysis and Forecast by Application

Global Male Hypogonadism Therapy Market Analysis and Forecast by Sales Channel

Global Male Hypogonadism Therapy Market Analysis and Forecast by Region

North America Male Hypogonadism Therapy Market Analysis and Forecast

Latin America Male Hypogonadism Therapy Market Analysis and Forecast

Europe Male Hypogonadism Therapy Market Analysis and Forecast

Asia Pacific Male Hypogonadism Therapy Market Analysis and Forecast

Asia Pacific Male Hypogonadism Therapy Market Size and Volume Forecast by Application

Middle East & Africa Male Hypogonadism Therapy Market Analysis and Forecast

Competition Landscape

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Male Hypogonadism Therapy Industry 2020 Market Size, Share, Price, Trend And Forecast To 2026- Industry Growth Insights - The Scarlet

Male Hypogonadism Market : Extensive Analysis of Key Segments of the Industry and Emerging Growth Factors with Current Trends and Future Estimations -…

According to Persistence Market Researchs new report, globalmale hypogonadism marketis slated to exhibit a steady expansion throughout the forecast period (2017-2026). Revenues from the global market for male hypogonadism are estimated to exceed US$ 3,300 Mn by 2026-end.

Governments Taking Initiatives to Spread Awareness about Male Hypogonadism Therapeutics

Lack of sex hormones, usually referred to as male hypogonadism has resulted into many health risks that include osteoporosis, heart disease, and cardiovascular diseases on the back of thinning of bones. Global male hypogonadism market comprises several patented brands that currently have high market penetration. Proliferation in geriatric population in tandem with rising incidences related to rheumatoid arthritis and obesity have been primary factors affecting prevalence of male hypogonadism globally.

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Company Profiles

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Mounting incidences of testosterone deficiency in male population is a key factor that prevalence of male hypogonadism has surged worldwide. Several governments around the world have been taking initiatives to spread the awareness on hypogonadism treatment procedures, for example testosterone replacement therapy (TST), in order to relieve the painful burden on patients and their families.

As low testosterone levels are increasingly associated with exacerbation of chronic conditions, it further results into disorders apropos to hypothalamic-pituitary-gonadal axis. Advent of TST has however enabled reduction in cases of male hypogonadism considerably. With growing awareness related to its treatment among patients, the market is likely to gain an uptick during the forecast period.

Rising availability of the selective androgen receptor modulators (SARMs) has further sustained the market expansion. The development and high availability of SARMs has led toward the provision of improved treatment procedure to patients having androgen deficiencies, thereby influencing the market growth.

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North America will continue to Dominate Global Male Hypogonadism Market

North America will continue to dominate the global male hypogonadism market, with more than one-third revenue share during the forecast period. In addition, revenues from the male hypogonadism market in North America will exhibit the fastest expansion through 2026, as compared to those from all the other regional segments comprised in the report. Europe and Asia-Pacific excluding Japan (APEJ) are also expected to remain lucrative for the male hypogonadism market. The market in APEJ will ride on a slightly higher CAGR than that in Europe through 2026.

Topical gels are expected to remain the most lucrative among drugs available for treatment of male hypogonadism globally, with sales projected to register the fastest expansion through 2026. Injectables will also remain a major revenue contributor to the market. Sales of injectable and transdermal patches are poised to reflect an equal CAGR through 2026.

Testosterone Replacement Therapy to Remain Preferred among Patients

Based on therapy, testosterone replacement therapy is expected to remain preferred among patients with male hypogonadism worldwide. Roughly 66% revenue share of the market is expected to be held by revenues from testosterone replacement therapy by 2026-end. Revenues from gonadotropin replacement therapy will remain slightly more than half revenues gained from testosterone replacement therapy throughout the forecast period.

Klinefelters syndrome is expected to remain the most prevalent disease type observed in the male hypogonadism market, and revenues from treatment of this disease will exceed US$ 1,800 Mn by 2026-end. Kallmann Syndrome and Pituitary Adenomas among disease types will also account for major revenue shares of the market by 2026-end.

Regions Covered In Report

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Male Hypogonadism Market : Extensive Analysis of Key Segments of the Industry and Emerging Growth Factors with Current Trends and Future Estimations -...

COVID-19 Impact On Hormone Replacement Therapy Market Size, Status And Forecast 2020-2026 – Galus Australis

The Global Hormone Replacement Therapy Market has witnessed continuous growth in the past few years and is projected to grow even further during the forecast period (2020-2026). The assessment provides a 360 view and insights, outlining the key outcomes of the industry. These insights help the business decision-makers to formulate better business plans and make informed decisions for improved profitability. In addition, the study helps venture capitalists in understanding the companies better and make informed decisions. This report studies the Global Hormone Replacement Therapy market size, industry status and forecast, competition landscape and growth opportunity.

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Hormone Replacement Therapy Market Segmentation:

Top leading Manufactures Profiled in Hormone Replacement Therapy Market Report are:

Eli Lilly, Abbott, Pfizer, Novo Nordisk, Merck KGaA, AbbVie, Teva, Mylan, Novartis, Bayer, Roche, ANI Pharmaceuticals, Ipsen, TherapeuticsMD, Endo International

Market Research Study Focus on these Types:

Estrogen Hormone, Growth Hormone, Thyroid Hormone, Testosterone Hormone, The proportion of estrogen hormone in 2018 is about 50%, and the proportion is in increasing trend from 2014 to 2018.

Market Research Study Focus on these Applications:

Menopause, Hypothyroidism, Growth Hormone Deficiency, Male Hypogonadism, Other Diseases, The most proportion of hormone replacement therapy is used in menopause, and the proportion in 2018 is 46.2%.

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The report highlights major developments and changing trends adopted by key companies over a period of time. For a stronger and more stable business outlook, the report on the global market carries key projections that can be practically studied.

Hormone Replacement Therapy Market analysis report has recently added by Research which helps to make informed business decisions. This research report further identifies the market segmentation along with their sub-types. The Hormone Replacement Therapy Market is expected to reach at a huge CAGR during the forecast period. Various factors are responsible for the markets growth, which are studied in detail in this research report.

Hormone Replacement Therapy Market Scenario:

This research report represents a 360-degree overview of the competitive landscape of the Hormone Replacement Therapy Market. Furthermore, it offers massive data relating to recent trends, technological advancements, tools, and methodologies. The research report analyzes the Hormone Replacement Therapy Market in a detailed and concise manner for better insights into the businesses.

Report evaluates the growth rate and the Market value based on Market dynamics, growth inducing factors. The complete knowledge is based on latest industry news, opportunities and trends. The report contains a comprehensive Market analysis and vendor landscape in addition to a SWOT analysis of the key vendors.

The key insights of the Hormone Replacement Therapy Market report:

The report provides key statistics on the market status of the Hormone Replacement Therapy market manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the industry.

The report provides a basic overview of the industry including its definition, applications and manufacturing technology.

The Hormone Replacement Therapy market report presents the company profile, product specifications, capacity, production value, and 2014-2020 market shares for key vendors.

The total market is further divided by company, by country, and by application/type for the competitive landscape analysis.

The report estimates 2020-2026 market development trends of Hormone Replacement Therapy Market.

Analysis of upstream raw materials, downstream demand and current market dynamics is also carried out

The report makes some important proposals for a new project of Hormone Replacement Therapy Industry before evaluating its feasibility.

In conclusion, Hormone Replacement Therapy market report presents the descriptive analysis of the parent market supported elite players, present, past and artistic movement information which is able to function a profitable guide for all the Hormone Replacement Therapy Industry business competitors. Our expert research analysts team has been trained to provide in-depth market research report from every individual sector which will be helpful to understand the industry data in the most precise way.

How we have factored the effect of Covid-19 in our report:

All the reports that we list have been tracking the impact of COVID-19 the market. Both upstream and downstream of the entire supply chain has been accounted for while doing this. Also, where possible, we will provide an additional COVID-19 update supplement/report to the report in Q3, please check for with the sales team.

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COVID-19 Impact On Hormone Replacement Therapy Market Size, Status And Forecast 2020-2026 - Galus Australis

Male Hypogonadism Therapy Market 2020 Size by Product Analysis, Application, End-Users, Regional Outlook, Competitive Strategies and Forecast to 2027…

New Jersey, United States,- The most recent Male Hypogonadism Therapy Market Research study includes some significant activities of the current market size for the worldwide Male Hypogonadism Therapy market. It presents a point by point analysis dependent on the exhaustive research of the market elements like market size, development situation, potential opportunities, and operation landscape and trend analysis. This report centers around the Male Hypogonadism Therapy business status, presents volume and worth, key market, product type, consumers, regions, and key players.

The COVID-19 pandemic has disrupted lives and is challenging the business landscape globally. Pre and Post COVID-19 market outlook is covered in this report. This is the most recent report, covering the current economic situation after the COVID-19 outbreak.

Key highlights from COVID-19 impact analysis:

Unveiling a brief about the Male Hypogonadism Therapy market competitive scope:

The report includes pivotal details about the manufactured products, and in-depth company profile, remuneration, and other production patterns.

The research study encompasses information pertaining to the market share that every company holds, in tandem with the price pattern graph and the gross margins.

Male Hypogonadism Therapy Market, By Type

Male Hypogonadism Therapy Market, By Application

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Male Hypogonadism Therapy Market 2020 Size by Product Analysis, Application, End-Users, Regional Outlook, Competitive Strategies and Forecast to 2027...

UB study finds testosterone therapy can lead to remission in men with Type 2 diabetes – UB Now: News and views for UB faculty and staff – University…

The findings from a recent study by a UB researcher and others could prove to be a game-changer for men with Type 2 diabetes.

The single-site study, conducted over 11 years in Bremerhaven, Germany, found that testosterone therapy reversed Type 2 diabetes in one-third of the study participants.

The occurrence of this syndrome is common, and with appropriate testosterone replacement, obesity insulin resistance and diabetes may be reversible, says Paresh Dandona, SUNY Distinguished Professor in the Department of Medicine in the Jacobs School of Medicine and Biomedical Sciences at UB. He co-authored the study, titled Remission of type 2 diabetes following long-term treatment with injectable testosterone undecanoate in patients with hypogonadism and type 2 diabetes: 11-year data from a real-world registry study.

The prospective, registry-based study was published in June in the online journal Diabetes, Obesity and Metabolism. Dandona also presented the data at the Annual Mohan Diabetes Foundation Symposium in Chennai, India, on July 25, where he was given the organizations Lifetime Achievement Award.

Type 2 diabetes, also known as Type 2 diabetes mellitus, results from a combination of insulin resistance and insufficient production of insulin, causing high blood sugar. The condition is common, with more than 3 million new cases per year in the United States. Reduced testosterone concentrations are found in 33% of men with Type 2 diabetes.

The discovery of this syndrome of hypogonadism in Type 2 diabetes was made by Dandonas group at UB in 2004. This group then extended the prevalence of this syndrome to include 25% of non-diabetic obese men in 2010. Thus, diabetes and obesity became the main cause of male hypogonadism. The group went on to demonstrate that such patients have additional insulin resistance that reverses with testosterone treatment in 2016.

Testosterone deficiency, which is also called male hypogonadism, contributes to reduced response of insulin to glucose, increased insulin resistance and eventually the onset of Type 2 diabetes.

The objective of the researchers study was to determine if men with Type 2 diabetes who also exhibit hypogonadism, when treated with testosterone in addition to their regular diabetes treatment, would demonstrate improved glycemic control and insulin sensitivity, and possibly eventually experience remission of Type 2 diabetes.

The investigators observed 356 men in a single urology practice clinic over 11 years. All patients received standard diabetes treatment, which included mandatory educational courses and materials. In addition, 178 men with a mean age of 62 years received 1,000 milligrams of subcutaneously injected, slow-release testosterone every 12 weeks after an initial six-week interval. The 178 subjects, mean age 64 years, who opted out of the testosterone therapy served as the control group.

The researchers took numerous measurements, including height, weight, waist circumference, blood pressure, hemoglobin, fasting glucose, HbA1c (the average amount of glucose in blood over a six- or 12-week period), insulin, heart rate, lipids, highly sensitive C-reactive protein and total testosterone, among others. They also assessed quality of life using the Aging Males Symptoms scale. Erectile function was also assessed, using the International Index of Erectile Function. Assessment of these clinical metrics was performed at least twice a year, and data over 11 years were analyzed.

The results showed that the men treated with testosterone had significant progressive and sustained reductions in their body weight, fasting glucose, HbA1c and fasting insulin over the treatment period, the authors wrote. In the control group, fasting glucose, HbA1c and fasting insulin increased.

One-third (34.3%) of men treated with testosterone saw remission of their diabetes; almost half (46.6%) achieved normal glucose regulation with antidiabetic treatment and a vast majority (83.1%) reached their target level of HbA1c.

Patients in the control group saw no remission of diabetes or reduction in glucose or HbA1c levels.

In addition, there were fewer deaths, myocardial infarctions, strokes and diabetic complications in the group treated with testosterone.

The research indicates that long-term treatment with testosterone is potentially a novel additional therapy for men with Type 2 diabetes and hypogonadism, the authors wrote.

The clinical significance of these results is further enhanced by the fact that one-third of men with Type 2 diabetes have hypogonadism. Hence, physicians encounter men with hypogonadism and diabetes very frequently. It is remarkable that while Type 2 diabetes mellitus leads to hypogonadism, treatment of hypogonadism results in remission of diabetes itself, the authors wrote.

Going forward, prospective randomized controlled trials are needed to confirm the data. One such trial is currently in progress.

Dandona is one of the worlds leading experts in the treatment of diabetes and vascular disease. He is also the ex-chief of endocrinology at UB and founder of the Diabetes and Endocrinology Center of Western New York, which is sponsored by the Jacobs School and Kaleida Heath. He sees patients at UBMD Internal Medicine.

Dandonas co-authors on the study include Karim Sultan Haider and Ahmad Haider, urologists in Bremerhaven, Germany; Farid Saad, a consultant to Medical Affairs Andrology at Bayer AG in Berlin; Gheorghe Doros from the Department of Epidemiology and Biostatistics at the Boston University School of Public Health; Markolf Hanefeld from GWT-TU Dresden GmbH and Medizinische Klinik, Universittsklinikum Carl Gustav Carus, in Dresden; Sandeep Dhindsa from the Division of Endocrinology, Diabetes and Metabolism at Saint Louis University; and Abdulmaged Traish from the Department of Urology at the Boston University School of Medicine.

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UB study finds testosterone therapy can lead to remission in men with Type 2 diabetes - UB Now: News and views for UB faculty and staff - University...

Male Hypogonadism Market 10-Year Market Forecast and Trends Analysis Research Report2017 2026 – The Daily Chronicle

A new report by XploreMR takes a deep dive into the Male Hypogonadism Market after conducting meticulous research, assessing each microscopic aspect of the market. The researches have connected the dots with minuscule details that shape into an intricate, immaculate yet elucidate study. The report presents a thoroughly scrutinized study of the Male Hypogonadism Market, leaving no stone unturned in offering market players a valuable and constructive tool that navigates them in the profitable path with the right set of objectives.

Following the methodology of Porters Five Forces analysis, the report emphasizes macro concepts such as the threat of new entries in the Male Hypogonadism Market, supplier power, threat of substitution, and buying power. Dwelling deeper into each of the factors, details about the competitive landscape, strategies of leading market players, and changes in the landscape, are also analyzed. In addition to competitive analysis, the researchers have also employed PESTEL analysis to study the impact of political, economic, social, technological, environmental, and legal factors on the keyword, thus leaving no loose ends.

ThisPress Release will help you to understand the Volume, growth with Impacting Trends. Click HERE To get SAMPLE PDF (Including Full TOC, Table & Figures) at https://www.xploremr.com/connectus/sample/517

The researchers have studied the factors that are expected to drive the growth of the Male Hypogonadism by creating revenue opportunities, directly and indirectly. Similarly, the emerging trends, both long-term and short-term, present factors that are likely to impact the markets growth and project the direction the whole market is moving. Economical, technological, or any other trend that could bestow opportunities, have been studied. Moreover, the researchers have expanded the analysis beyond growth prospects and analyzed the possible restraining factors to the growth of the Male Hypogonadism Market, thus enabling market players to foresee the likely challenges and emerge successful through the forecast period 2017 2026.

In addition to the macro-economic factors that drive the global market, the market divulges micro-economic factors, diving into each individual segment such as geographical, end-use segments, and products, among others, and studies each of the segments with respect to different geographies. The geography-specific insights paint a crystal clear picture of the growth of every individual segment studied in the report, thereby enabling regional market players to leverage the trends in the region.

The report assesses key players in the Male Hypogonadism Market, studying their services, strategies, landmarks, growth plans, and recent developments. By studying multiple organizations covering small, medium, and large players the report enables emerging players to equip themselves with knowledge of competition scenarios. The most critical aspect in the competitive landscape individual growth strategy is studied extensively by dwelling into the foregoing growth trajectory of the organization. Moreover, the study paints a picture of the individual standpoints of the players in the years to come, considering the drivers and trends.

To breakdown the vast study that spreads through geographies, products, and end-use segments, among other market-specific segments, the authors present CAGR (Compound Annual Growth Rate) of each segment throughout the years of forecast. CAGR is a simplistic representation of growth that clearly projects which segment registered the highest/least growth through the forecast period 2017 2026. Moreover, each segment is analyzed on the basis of volume and volume, also projected with year-on-year growth and CAGR.

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Researchers also present production and consumption analysis, key findings, important suggestions and recommendations, and other aspects, thus offering a comprehensive picture of the Male Hypogonadism Market to bolster market players in planning their strategies in the years to come.

Important Questions Answered

Highlights of TOC:

Overview: Presents a broad overview of the Male Hypogonadism market, acting as a snapshot of the elaborate study that follows.

Market Dynamics: A straight-forward discussion about key drivers, restraints, challenges, trends, and opportunities of the Male Hypogonadism market.

Product Segments: Explores the market growth of the wide variety of products offered by organizations, and how they fare with end-users.

Application Segments: This section studies the key end-use applications that contribute to the market growth and the emerging opportunities to the Male Hypogonadism market.

Geographical Segments: Each regional market with a region-specific study of each segment- is carefully assessed for understanding its current and future growth scenarios.

Company Profiles: Leading and emerging players of the Male Hypogonadism Market are thoroughly profiled in the report based on their market share, market served, products, applications, regional growth, and other factors.

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Male Hypogonadism Market 10-Year Market Forecast and Trends Analysis Research Report2017 2026 - The Daily Chronicle

UB diabetes expert’s research shows testosterone therapy can lead to remission in men with Type 2 diabetes – UB News Center

BUFFALO, N.Y. The findings from a recent study by a University at Buffalo researcher and others could prove to be a game-changer for men with Type 2 diabetes.

The single-site study, conducted over 11 years in Bremerhaven, Germany, found that testosterone therapy reversed Type 2 diabetes in a one-third of the study participants.

The occurrence of this syndrome is common and with appropriate testosterone replacement, obesity insulin resistance and diabetes may be reversible, said Paresh Dandona, MD, PhD, SUNY Distinguished Professor in the Department of Medicine in the Jacobs School of Medicine and Biomedical Sciences at UB. He co-authored the study, titled Remission of type 2 diabetes following long-term treatment with injectable testosterone undecanoate in patients with hypogonadism and type 2 diabetes: 11-year data from a real-world registry study.

The prospective, registry-based study was published in the online journal Diabetes, Obesity and Metabolism in June. Dandona also presented the data to the Annual Mohan Diabetes Foundation Symposium in Chennai, India, on July 25, where he was given the organizations Lifetime Achievement Award.

Type 2 diabetes, also known as Type 2 diabetes mellitus, results from a combination of insulin resistance and insufficient production of insulin, causing high blood sugar. The condition is common, with more than 3 million new cases per year in the United States. Reduced testosterone concentrations are found in 33% of men with Type 2 diabetes.

The discovery of this syndrome of hypogonadism in Type 2 diabetes was made by Dandonas group at UB in 2004. This group then extended the prevalence of this syndrome to include 25% of non-diabetic obese men in 2010. Thus, diabetes and obesity became the main cause of male hypogonadism. The group went on to demonstrate that such patients have additional insulin resistance that reverses with testosterone treatment in 2016.

Testosterone deficiency, which is also called male hypogonadism, contributes to reduced response of insulin to glucose, increased insulin resistance and eventually the onset of Type 2 diabetes.

The objective of the researchers study was to determine if men with Type 2 diabetes who also exhibit hypogonadism, when treated with testosterone in addition to their regular diabetes treatment, would demonstrate improved glycemic control and insulin sensitivity and possibly eventually experience remission of Type 2 diabetes.

The investigators observed 356 men in a single urology practice clinic over 11 years. All patients received standard diabetes treatment, which included mandatory educational courses and materials. In addition, 178 men with a mean age of 62 years, received 1,000 milligrams of subcutaneously injected, slow-release testosterone every 12 weeks after an initial six-week interval. The 178 subjects, mean age 64 years, who opted out of the testosterone therapy served as the control group.

The researchers took numerous measurements, including height, weight, waist circumference, blood pressure, hemoglobin, fasting glucose, HbA1c (the average amount of glucose in blood over a 6 or 12 week period), insulin, heart rate, lipids, highly sensitive C-reactive protein and total testosterone among others. They also assessed quality of life using the Aging Males Symptoms scale. Erectile function was also assessed, using the International Index of Erectile Function. Assessment of these clinical metrics was performed at least twice a year, and data over 11 years were analyzed.

The results showed that the men treated with testosterone had significant progressive and sustained reductions in their body weight, fasting glucose, HbA1c and fasting insulin over the treatment period, the authors wrote. In the control group, fasting glucose, HbA1c and fasting insulin increased.

One-third (34.3%) of men treated with testosterone saw remission of their diabetes; almost half (46.6%) achieved normal glucose regulation with antidiabetic treatment and a vast majority (83.1%) reached their target level of HbA1c.

Patients in the control group saw no remission of diabetes or reduction in glucose or HbA1c levels were noted.

In addition, there were fewer deaths, myocardial infarctions, strokes, and diabetic complications in the group treated with testosterone.

The research indicates that long-term treatment with testosterone is potentially a novel additional therapy for men with Type 2 diabetes and hypogonadism, the authors wrote.

The clinical significance of these results is further enhanced by the fact that one-third of men with Type 2 diabetes have hypogonadism. Hence, physicians encounter men with hypogonadism and diabetes very frequently. It is remarkable that while Type 2 diabetes mellitus leads to hypogonadism, treatment of hypogonadism results in remission of diabetes itself, the authors wrote.

Going forward, prospective randomized controlled trials are needed to confirm the data. One such trial is currently in progress.

Dandona is one of the worlds leading experts in the treatment of diabetes and vascular disease. He is also the ex-chief of endocrinology at UB and the founder of the Diabetes and Endocrinology Center of Western New York, which is sponsored by the Jacobs School and Kaleida Heath. He sees patients at UBMD Internal Medicine.

Dandonas co-authors on the study include Karim Sultan Haider, MD, and Ahmad Haider, MD, urologists in Bremerhaven, Germany; Farid Saad, PhD, a consultant to Medical Affairs Andrology at Bayer AG in Berlin; Gheorghe Doros,, PhD, from the Department of Epidemiology and Biostatistics at the Boston University School of Public Health; Markolf Hanefeld, MD, from GWT-TU Dresden GmbH and Medizinische Klinik, Universittsklinikum Carl Gustav Carus, in Dresden; Sandeep Dhindsa, MD, from the Division of Endocrinology, Diabetes and Metabolism at Saint Louis University; and Abdulmaged Traish, PhD, from the Department of Urology at the Boston University School of Medicine.

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UB diabetes expert's research shows testosterone therapy can lead to remission in men with Type 2 diabetes - UB News Center

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