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Archive for the ‘Hypogonadism’ Category

Testosterone Therapy for Hypogonadism Guideline Resources …

Full Guideline: Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice GuidelineJCEM | March 2018

Shalender Bhasin, Juan P. Brito, Glenn R. Cunningham, Frances J. Hayes, Howard N. Hodis, Alvin M. Matsumoto, Peter J. Snyder, Ronald S. Swerdloff, Frederick C. Wu, Maria A. Yialamas

Differences between the 2010 and 2018 guidelines:

+1.0 Diagnosis of Hypogonadism in Men

1.1 We recommend diagnosing hypogonadism in men with symptoms and signs of testosterone deficiency and unequivocally and consistently low serum total testosterone and/or free testosteroneconcentrations (when indicated). (1 |O)

1.2 We recommend against routine screening of men in the general population for hypogonadism. (1 |OO)

1.3 In men who have hypogonadism, we recommend distinguishing between primary (testicular) and secondary (pituitaryhypothalamic) hypogonadism by measuring serum luteinizing hormone and follicle stimulating hormone concentrations. (1 |O)

1.4 In men with hypogonadism, we suggest further evaluation to identify the etiology of hypothalamic, pituitary, and/or testicular dysfunction. (2 |OO)

+2.0 Treatment of Hypogonadism with Testosterone

2.1 We recommend testosterone therapy in hypogonadal men to induce and maintain secondarysex characteristics and correct symptoms of testosterone deficiency. (1 |O)

2.2. We recommend against testosterone therapy in men planning fertility in the near term or in men with breast or prostate cancer, a palpable prostate nodule or induration, a prostate-specific antigen level >4 ng/mL, a prostate-specific antigen level >3 ng/mL combined with a high risk of prostate cancer(without further urological evaluation), elevated hematocrit, untreated severe obstructive sleep apnea,severe lower urinary tract symptoms, uncontrolled heart failure, myocardial infarction or stroke withinthe last 6 months, or thrombophilia. (1 |OO)

2.3 In hypogonadal men 55 to 69 years old, who are being considered for testosterone therapy andhave a life expectancy >10 years, we suggest discussing the potential benefits and risks of evaluatingprostate cancer risk and prostate monitoring and engaging the patient in shared decision makingregarding prostate cancer monitoring. For patients who choose monitoring, clinicians should assessprostate cancer risk before starting testosterone treatment and 3 to 12 months after starting testosterone. (2 |OOO) In hypogonadal men being considered for testosterone therapy who are 40 to69 years old and at increased risk of prostate cancer (e.g., African Americans and men with a first-degreerelative with diagnosed prostate cancer), we suggest discussing prostate cancer risk with the patient andoffering monitoring options. (2 |OOO)

2.4 We suggest against routinely prescribing testosterone therapy to all men 65 years or older withlow testosterone concentrations (1 |OO). In men.65 years who have symptoms or conditionssuggestive of testosterone deficiency (such as low libido or unexplained anemia) and consistentlyand unequivocally low morning testosterone concentrations, we suggest that clinicians offertestosterone therapy on an individualized basis after explicit discussion of the potential risks andbenefits. (2 |OO)

2.5 We suggest that clinicians consider short-term testosterone therapy in HIV-infected men with low testosterone concentrations and weight loss (when other causes of weight loss have been excluded)to induce and maintain body weight and lean mass gain. (2 |OO)

2.6 In men with type 2 diabetes mellitus who have low testosterone concentrations, we recommendagainst testosterone therapy as a means of improving glycemic control. (1 |OO)

+3.0 Monitoring of Testosterone Replacement Therapy

3.1 In hypogonadal men who have started testosterone therapy, we recommend evaluating the patient after treatment initiation to assess whether the patient has responded to treatment, is suffering any adverse effects, and is complying with the treatment regimen. (Ungraded Good Practice Statement)

3.2 We recommend a urological consultation for hypogonadal men receiving testosterone treatmentif during the first 12 months of testosterone treatment there is a confirmed increase in prostate specificantigen concentration >1.4 ng/mL above baseline, a confirmed prostate-specific antigen >4.0 ng/mL, or a prostatic abnormality detected on digital rectal examination. After 1 year, prostate monitoring should conform to standard guidelines for prostate cancer screening based on the race and age of the patient. (2 |OO)

Read the rest here:
Testosterone Therapy for Hypogonadism Guideline Resources ...

Clarus Therapeutics And HavaH Therapeutics Announce Licensing Agreement For Product To Treat Androgen-Dependent Inflammatory Breast Disease And…

If approved, CLAR-121 would be the first T treatment of its kind for inflammatory breast disease.

HavaH has extensive clinical experience with CLAR-121 in more than 1,000 Australian women (more than 6,200 implants) with breast disease, and Clarus expects that access to HavaH's pharmacokinetics, safety and early efficacy data in PDM will expedite progression to Phase 2/3 clinical studies in the U.S. Clarus estimates that the annual U.S. market size for PDM exceeds $400 million.2,3,4With this new pipeline asset, Clarus may also pursue, alone or in partnership, future indications in ER+ breast cancer, macromastia, granulomatous mastitis, and autoimmune induced breast pain.

"This licensing agreement marks the beginning of an exciting new partnership with HavaH. Their experience coupled with the significant amount of clinical data generated in Australia will benefit Clarus greatly as we begin our development activities in the U.S.," said Dr. Robert Dudley, Clarus's founder, president and CEO. "CLAR-121 allows us to leverage our expertise in androgen biology, as exemplified by JATENZO, a testosterone replacement therapy (TRT) for male hypogonadism and Clarus's first commercial product, and expands our development pipelinewith an initial focus on PDM in women a debilitating, painful disease with very limited treatment options, short of invasive surgery. This treatment, if approved, has the potential to be life-changing for women who suffer from PDM, and its development fits well with our mantra: 'good is never good enough'. Our goal is to provide treatment options that not only produce a positive clinical outcome, but also provide a positive therapeutic experience for patients."

Under the terms of the licensing agreement, Clarus will be responsible for future global development and regulatory activities for CLAR-121, excluding Australia. Clarus will pay HavaH an upfront payment of $500,000 upon signing and HavaH may be eligible for up to $10.75 million in potential development and regulatory milestone payments. HavaH will retain the right to promote HAVAH T+Aiin Australia. Additionally, HavaH would be eligible for a modest royalty and up to $30 million in potential commercial milestones.

"We developed HAVAH T+Ai to address a significant unmet need in women's health, and our partnership with Clarus will enable us to advance this therapeutic approach not only for inflammatory breast disease but, more widely we hope, for ER+ breast cancer where data now unambiguously demonstrates that the androgen receptor has an important tumor suppressor role in this form of breast cancer,"5 said Stephen Birrell, MD, PhD, HavaH founder, chairman and chief medical officer.

"In Clarus, we found a partner who understands and appreciates the potentially profound importance of androgen action in the context of inflammatory breast disease, as well as its role as an adjunctive endocrine therapy for certain forms of breast cancer," said Kathy Harrison, HavaH CEO.

Reedland Capital Partners, acting through Weild & Co., member FINRA/SIPC, served as financial advisor to HavaH in connection with this transaction. For more information, please visit http://www.reedland.com.

About Clarus Therapeutics, Inc.

Clarus is a pharmaceutical company with expertise and interest in developing androgen and metabolic therapies for men and women, including potential therapies for orphan indications.Clarus successfully developed and brought to market JATENZO (testosterone undecanoate oral capsules; CIII) a new state-of-the-art oral TRT. JATENZO was launched in February 2020 as the first and only FDA-approved oral softgel for TRT in adult males who have low or no testosterone due to certain medical conditions.6,7,8For more information, visit http://www.clarustherapeutics.com and http://www.JATENZO.com.

At the end of April, Clarus announced a new chapter for the company as it entered into a definitive business combination agreement with Blue Water Acquisition Corp. (NASDAQ: BLUW), a special purpose acquisition company (SPAC), that will result in Clarus becoming a publicly traded company when the transaction closes in the third quarter of 2021.

About HavaH Therapeutics

HavaH Therapeutics is an Australia-based women's hormonal health biopharmaceutical company founded in 2005. HavaH's transition into the U.S. market was facilitated by the appointment in 2017 of San Francisco-based Executive Director Ronald Martell.

HavaH is developing innovative, proprietary hormonal therapies that aim to improve quality of life for women across the world. HavaH brings together a world-class team passionate about helping women live lives free from the suffering caused by breast pain, debilitating menopausal symptoms and breast cancer. More information is available at http://www.havahtx.com

Clarus Forward-Looking Statement

Certain statements in this press release and the information incorporated herein by reference may constitute "forward-looking statements" for purposes of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, including those relating to the success, cost and timing of our product development activities and clinical trials, including our estimates regarding timing to commence future clinical trials, the potential attributes and benefits of our product candidates, the potential attributes and benefits of product candidates, including CLAR-121, our ability to obtain and maintain regulatory approval for our product candidates and our ability to obtain funding for our operations when needed. Forward-looking statements include statements relating to our management team's expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading "Risk Factors" in the preliminary proxy/prospectus for our proposed business combination, and those that are included in any of our future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by the COVID-19 pandemic and there may be additional risks that we consider immaterial, or which are unknown. It is not possible to predict or identify all such risks. Our forward-looking statements only speak as of the date they are made, and we do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

About JATENZO

Indication

JATENZO (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

Limitation of use

Safety and efficacy of JATENZO in males less than 18 years old have not been established.

IMPORTANT SAFETY INFORMATION

WARNING: INCREASES IN BLOOD PRESSURE

CONTRAINDICATIONS

JATENZO is contraindicated in men with breast cancer or known or suspected prostate cancer. JATENZO is contraindicated in women who are pregnant as testosterone may cause fetal harm.

WARNINGS AND PRECAUTIONS

ADVERSE EVENTS

The most common adverse events of JATENZO (incidence 2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).

These are not all the risks associated with JATENZO. For more information, click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure. You can also obtain information regarding JATENZO at http://www.jatenzo.com.

1 Zhang, Yanna et al. Clinical characteristics, classification, and surgical treatment of periductal mastitis. J Thorac Dis 2018; 10(4): 2420-2427.

2 Dixon JM, et al. Periductal mastitis and duct ectasia: different conditions with different aetiologies. Br J Surg 1996; 83: 820-822.

3 Eberl MM, Phillips RL, Jr., Lamberts, H, et al. Characterizing breast symptoms in family practice. Ann Fam Med 2008; 6(6):528-33.

4 US Census Bureau, accessed on 06/15/2020: https://ftp.cdc.gov/pub/Health_Statistics/NCHS/NHIS/SHS/2018_SHS_Table_A-18.pdf.

5 Hickey, TE, Selth, LA, Chia, KM, et al. The androgen receptor is a tumor suppressor in estrogen receptor positive breast cancer. Nat. Med. 2021; 27: 310-320.

6 JATENZO (testosterone undecanoate) [prescribing information]. Clarus Therapeutics, Inc.

7 US Food & Drug Administration. FDA Approved Drug Products. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206089. Accessed October 1, 2019.

8 US Food & Drug Administration. NDA Approval Letter. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206089Orig1s000ltr.pdf

SOURCE Clarus Therapeutics Inc.

https://clarustherapeutics.com/

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Clarus Therapeutics And HavaH Therapeutics Announce Licensing Agreement For Product To Treat Androgen-Dependent Inflammatory Breast Disease And...

Trending Report of Male Hypogonadism Market Drivers, Strategies, Applications and Competitive Landscape 2026 Brockville Observer – Brockville…

InForGrowth added a new report on Male Hypogonadism Market Growth Analysis 2021-2026 provides an in-depth study on the current state of the global Industry by explicating the key development trends, limitations, challenges, and opportunities that will mold the business dynamics in the coming years. Also, the Male Hypogonadism Market report highlights the top regional markets and reveals the major areas to further business development, while providing a comprehensive account of the prominent companies in this domain. Apart from this, it also gauges the impact of the COVID-19 pandemic on revenue generation and breaks down the business strategies employed by well-established organizations to adapt to the changes in this industry.

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Trending Report of Male Hypogonadism Market Drivers, Strategies, Applications and Competitive Landscape 2026 Brockville Observer - Brockville...

Male menopause: Here’s everything you need to know about andropause – Pulse Ghana

If scientific studies are to be believed, men also go through hormonal changes after the age of 50. However, it is very different from what women go through.

This has been a controversial topic for several years. According to a study, male menopause is nothing like female menopause. Female menopause is a natural part of ageing for women, whereas, male menopause doesnt even affect some older men. Due to the significant differences between the two conditions, doctors prefer calling it andropause or late-onset hypogonadism.

In andropause, the production of testosterone and other hormones decline in men. Testosterone is a hormone that leads to changes during puberty, manages your physical and mental health, maintains muscle mass, fuels sex drive and other important functions in the body.

The condition is also known as testosterone deficiency and late-onset hypogonadism. It is often associated with hypogonadism, which shows similar symptoms to this condition.

Here is everything you need to know about andropause or male menopause.

As per studies, this condition can cause a variety of symptoms and complications in the body.

Not able to focus on things

Reduced bone density and muscle mass

Your doctor might take a blood sample to test your testosterone levels. However, in most cases, the symptoms are manageable without treatment. Making healthy lifestyle choices can help you alleviate the symptoms. So, eating healthy, regular exercise, adequate sleep, and less stress are some lifestyle changes that may help.

In case youre experiencing depression, your doctor may prescribe antidepressants, therapy and the above-mentioned lifestyle changes.

Read the original:
Male menopause: Here's everything you need to know about andropause - Pulse Ghana

Blue Water Acquisition : Clarus Therapeutics And HavaH Therapeutics Announce Licensing Agreement For Product To Treat Androgen-Dependent Inflammatory…

Clarus Therapeutics And HavaH Therapeutics Announce Licensing Agreement For Product To Treat Androgen-Dependent Inflammatory Breast Disease And Certain Forms Of Breast Cancer

Agreement aims to accelerate development of a unique testosterone treatment for inflammatory breast diseases and estrogen-receptor positive breast cancer

NORTHBROOK, Ill. and NORTH ADELAIDE, South Australia, May 25, 2021 /PRNewswire/ -- Clarus Therapeutics Inc. ('Clarus'), a pharmaceutical company dedicated to providing solutions to unmet medical needs by advancing androgen and metabolic therapies for men and women, and HavaH Therapeutics ('HavaH'), an Australia-based biopharmaceutical company developing androgen therapies for inflammatory breast disease and certain forms of breast cancer by using the innate breast-tissue-specific hormone/immune interface, today announced a licensing agreement whereby Clarus will acquire the exclusive worldwide (excluding Australia) development and commercialization rights for HAVAH T+Ai (CLAR-121).

If approved, CLAR-121 would be the first T treatment of its kind for inflammatory breast disease.

CLAR-121 is a proprietary combination of testosterone (T) (natural ligand for the androgen receptor; AR) and anastrozole (inhibitor of T conversion to estradiol) delivered by a subcutaneous implant for treatment of AR-mediated breast disease that predominantly affects women. If approved, CLAR-121 would be the first T treatment of its kind for inflammatory breast disease, including inflammatory periductal mastitis (PDM) and estrogen receptor-positive (ER+) breast cancer. Clarus's initial clinical development target is PDM - a destructive autoimmune inflammatory process of the retro-areolar milk ducts that results in multiple fistulae and inevitably results in disfiguring surgery and a high risk of recurrence. There is no known treatment for this condition apart from surgery, which has significant limitations.1 Due to the low prevalence of PDM in the U.S., Clarus anticipates this disease could qualify for orphan drug designation by the U.S. Food and Drug Administration and plans to petition the agency for that status for CLAR-121.

HavaH has extensive clinical experience with CLAR-121 in more than 1,000 Australian women (more than 6,200 implants) with breast disease, and Clarus expects that access to HavaH's pharmacokinetics, safety and early efficacy data in PDM will expedite progression to Phase 2/3 clinical studies in the U.S. Clarus estimates that the annual U.S. market size for PDM exceeds $400 million.2,3,4 With this new pipeline asset, Clarus may also pursue, alone or in partnership, future indications in ER+ breast cancer, macromastia, granulomatous mastitis, and autoimmune induced breast pain.

'This licensing agreement marks the beginning of an exciting new partnership with HavaH. Their experience coupled with the significant amount of clinical data generated in Australia will benefit Clarus greatly as we begin our development activities in the U.S.,' said Dr. Robert Dudley, Clarus's founder, president and CEO. 'CLAR-121 allows us to leverage our expertise in androgen biology, as exemplified by JATENZO, a testosterone replacement therapy (TRT) for male hypogonadism and Clarus's first commercial product, and expands our development pipeline with an initial focus on PDM in women - a debilitating, painful disease with very limited treatment options, short of invasive surgery. This treatment, if approved, has the potential to be life-changing for women who suffer from PDM, and its development fits well with our mantra: 'good is never good enough'. Our goal is to provide treatment options that not only produce a positive clinical outcome, but also provide a positive therapeutic experience for patients.'

Under the terms of the licensing agreement, Clarus will be responsible for future global development and regulatory activities for CLAR-121, excluding Australia. Clarus will pay HavaH an upfront payment of $500,000 upon signing and HavaH may be eligible for up to $10.75 million in potential development and regulatory milestone payments. HavaH will retain the right to promote HAVAH T+Ai in Australia. Additionally, HavaH would be eligible for a modest royalty and up to $30 million in potential commercial milestones.

'We developed HAVAH T+Ai to address a significant unmet need in women's health, and our partnership with Clarus will enable us to advance this therapeutic approach not only for inflammatory breast disease but, more widely we hope, for ER+ breast cancer where data now unambiguously demonstrates that the androgen receptor has an important tumor suppressor role in this form of breast cancer,'5 said Stephen Birrell, MD, PhD, HavaH founder, chairman and chief medical officer.

'In Clarus, we found a partner who understands and appreciates the potentially profound importance of androgen action in the context of inflammatory breast disease, as well as its role as an adjunctive endocrine therapy for certain forms of breast cancer,' said Kathy Harrison, HavaH CEO.

Reedland Capital Partners, acting through Weild & Co., member FINRA/SIPC, served as financial advisor to HavaH in connection with this transaction. For more information, please visit http://www.reedland.com.

About Clarus Therapeutics, Inc.

Clarus is a pharmaceutical company with expertise and interest in developing androgen and metabolic therapies for men and women, including potential therapies for orphan indications. Clarus successfully developed and brought to market JATENZO (testosterone undecanoate oral capsules; CIII) - a new state-of-the-art oral TRT. JATENZO was launched in February 2020 as the first and only FDA-approved oral softgel for TRT in adult males who have low or no testosterone due to certain medical conditions.6,7,8 For more information, visit http://www.clarustherapeutics.com and http://www.JATENZO.com.

At the end of April, Clarus announced a new chapter for the company as it entered into a definitive business combination agreement with Blue Water Acquisition Corp. (NASDAQ: BLUW), a special purpose acquisition company (SPAC), that will result in Clarus becoming a publicly traded company when the transaction closes in the third quarter of 2021.

About HavaH Therapeutics

HavaH Therapeutics is an Australia-based women's hormonal health biopharmaceutical company founded in 2005. HavaH's transition into the U.S. market was facilitated by the appointment in 2017 of San Francisco-based Executive Director Ronald Martell.

HavaH is developing innovative, proprietary hormonal therapies that aim to improve quality of life for women across the world. HavaH brings together a world-class team passionate about helping women live lives free from the suffering caused by breast pain, debilitating menopausal symptoms and breast cancer. More information is available at http://www.havahtx.com

Clarus Forward-Looking Statement

Certain statements in this press release and the information incorporated herein by reference may constitute 'forward-looking statements' for purposes of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, including those relating to the success, cost and timing of our product development activities and clinical trials, including our estimates regarding timing to commence future clinical trials, the potential attributes and benefits of our product candidates, the potential attributes and benefits of product candidates, including CLAR-121, our ability to obtain and maintain regulatory approval for our product candidates and our ability to obtain funding for our operations when needed. Forward-looking statements include statements relating to our management team's expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words 'anticipate,' 'believe,' 'contemplate,' 'continue,' 'could,' 'estimate,' 'expect,' 'intends,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'should,' 'will,' 'would' and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading 'Risk Factors' in the preliminary proxy/prospectus for our proposed business combination, and those that are included in any of our future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by the COVID-19 pandemic and there may be additional risks that we consider immaterial, or which are unknown. It is not possible to predict or identify all such risks. Our forward-looking statements only speak as of the date they are made, and we do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

About JATENZO

Indication

JATENZO (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

Limitation of use

Safety and efficacy of JATENZO in males less than 18 years old have not been established.

IMPORTANT SAFETY INFORMATION

WARNING: INCREASES IN BLOOD PRESSURE

CONTRAINDICATIONS

JATENZO is contraindicated in men with breast cancer or known or suspected prostate cancer. JATENZO is contraindicated in women who are pregnant as testosterone may cause fetal harm.

WARNINGS AND PRECAUTIONS

ADVERSE EVENTS

The most common adverse events of JATENZO (incidence 2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).

These are not all the risks associated with JATENZO. For more information, click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure. You can also obtain information regarding JATENZO at http://www.jatenzo.com.

1 Zhang, Yanna et al. Clinical characteristics, classification, and surgical treatment of periductal mastitis. J Thorac Dis 2018; 10(4): 2420-2427.

2 Dixon JM, et al. Periductal mastitis and duct ectasia: different conditions with different aetiologies. Br J Surg 1996; 83: 820-822.

3 Eberl MM, Phillips RL, Jr., Lamberts, H, et al. Characterizing breast symptoms in family practice. Ann Fam Med 2008; 6(6):528-33.

4 US Census Bureau, accessed on 06/15/2020: https://ftp.cdc.gov/pub/Health_Statistics/NCHS/NHIS/SHS/2018_SHS_Table_A-18.pdf.

5 Hickey, TE, Selth, LA, Chia, KM, et al. The androgen receptor is a tumor suppressor in estrogen receptor - positive breast cancer. Nat. Med. 2021; 27: 310-320.

6 JATENZO (testosterone undecanoate) [prescribing information]. Clarus Therapeutics, Inc.

7 US Food & Drug Administration. FDA Approved Drug Products. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206089. Accessed October 1, 2019.

8 US Food & Drug Administration. NDA Approval Letter. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206089Orig1s000ltr.pdf

Disclaimer

Blue Water Acquisition Corporation published this content on 25 May 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 May 2021 16:46:07 UTC.

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Blue Water Acquisition : Clarus Therapeutics And HavaH Therapeutics Announce Licensing Agreement For Product To Treat Androgen-Dependent Inflammatory...

Hormone Replacement Therapy Market Size to Surpass US$ 36.54 Billion by 2027 with the CAGR of 8.20% The Manomet Current – The Manomet Current

Hormone Replacement Therapy Market is valued atUSD 21.04 Billionin 2020 and expected to reachUSD 36.54 Billionby 2027 with theCAGR of 8.20%over the forecast period.

Global Hormone Replacement Therapy Market: Global Size, Trends, Competitive, Historical & Forecast Analysis, 2021-2027The growing awareness on post-menopausal issues among women is one of the major factors driving the growth of Global Hormone Replacement Therapy Market.

Get Sample Report:@ https://brandessenceresearch.com/requestSample/PostId/1402

Hormone replacement therapy is a treatment used to release symptoms of the menopause. The main advantage is that it is a very effective method of controlling menopausal symptoms, and it can make an important difference to a womans quality of life and security. Hormone replacement therapy can also reduce a womans risk of developing osteoporosis and cancer of the colon and rectum. Additionally, hormones are secreted predominantly from the endocrine glands and absorbed into the bloodstream. The hormones that have been most commonly utilised in hormone replacement therapy are progesterone, estrogen, testosterone, adrenal hormones, DHEA, thyroid hormones, pregnenolone, melatonin, and human growth hormone. It is the most effective treatment for menopause symptoms. Systemic hormone replacement therapy helps in treating cancer, rheumatoid arthritis and other diseases. Moreover, this treatment is particularly favorable for patients with growth hormone deficiency, women nearing menopause and elderly people suffering from hypogonadism. It may also protect against osteoporosis.

Global Hormone Replacement Therapy market report is segmented on the basis of product, administration, disease and region & country level. Based upon product, global hormone replacement therapy market is classified into estrogen replacement therapy, human growth hormone replacement therapy, thyroid replacement therapy and testosterone replacement therapy. Based upon administration, the market is divided into oral, parenteral and transdermal. Based upon disease, global hormone replacement therapy market is classified into menopause, hypothyroidism, male hypothyroidism, growth hormone deficiency, cancer and other.

The regions covered in this Hormone Replacement Therapy market report are North America, Europe, Asia-Pacific and Rest of the World. On the basis of country level, market of Hormone Replacement Therapy sub divided into U.S., Mexico, Canada, U.K., France, Germany, Italy, China, Japan, India, South East Asia, GCC, Afria, etc.

Global Hormone Replacement Therapy report covers prominent players Abbott Laboratories, Novo Nordisk, Novartis, Merck Serono, Bayer Healthcare, Eli Lilly, Mylan Laboratories, Roche, Genentech, Orion Pharma AB, Allergen Plc and others.

News-

September 12th, 2017; after a massive study of hormone replacement therapy was halted due to higher rates of breast cancer, heart attack and stroke among women assigned to the drugs to treat menopausal symptoms, a new follow-up study has found those women had no higher risk of death as of 2014 than participants who took a placebo.

Increasing healthcare expenditure due to growing awareness about health related problems. For example, According to OECD, the US spent $10,209 on healthcare per capita, or per person, in 2017. Thats more than any other country in OECDs 36-country consortium, and over $2,000 more than Switzerland, the second-highest spending country. In addition, rising drug development and hormonal imbalance disorders with rising geriatric population are also boosting the hormone replacement therapy market growth. Additionally, the rising womens population between the age group of 45 to 60, which increases the range of menopausal window due to this factor the demand of hormonal replacement therapy, is also growing. However, the hormone replacement therapy has number of side effects which may hamper the market growth. For example, fluid retention, indigestion, headache, and depression, bloating, swelling, nausea, leg cramps. Combined hormone replacement therapy slightly increases the risk of developing breast cancer, womb cancer, ovarian cancer and stroke. For example, Women who take hormone replacement therapy for more than 1 year have a higher risk of breast cancer than women who never use hormone replacement therapy. The risk is linked to all types of hormone replacement therapy except vaginal oestrogen. In spite of that, technological advancements in this field may create the number of opportunities within the forecast period.

North America is expected to dominate the global hormone replacement therapy market due to the increasing awareness about the hormonal replacement therapy And Increasing number of womens which have menopause problems in this region. For example, National Center for Biotechnology Information, in the United States, approximately 1.3 million women become menopausal each year and, 1% of women experience premature menopause before the age of 40. The Asia Pacific is expected to experience surge of demand too, owing to the factors such as increased awareness levels among the end users and improving healthcare infrastructure. Rising geriatric population is one of the primary factors responsible for the growth of the hormonal replacement therapy marketin the Europe.

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Hormone Replacement Therapy Market Size to Surpass US$ 36.54 Billion by 2027 with the CAGR of 8.20% The Manomet Current - The Manomet Current

The many effects of reproductive hormones on the brain – ESHRE

The aim of a well attended Campus meeting organised by the SIG Reproductive Endocrinology in May was to present the latest findings on how sex hormones from various organs influence the brain, not vice versa and to emphasise that theres a psychological as well as physical effect in women.

The first part of the meeting provided a comprehensive update on the basics of how hormones - neuropeptides, AMH and hormonal contraceptives - affect the brain, and may even trigger depression and suicidal thoughts as a result of menstrual cycle syndromes.

Richard Anderson from the University of Edinburgh presented evidence on the key role that the so-called KNDy neurons expressing kisspeptin play in stimulating GnRH and LH, with elevated/fast secretion of these gonadotrophins a feature in PCOS patients. Therapeutic applications based on partial GnRH suppression may become available for PCOS and other conditions using NK3 receptor antagonists, and large clinical trials are under way. NK3 therapies have been associated in trials with a remarkable reduction in menopausal hot flushes, which are linked to GnRH pulses, according to Anderson.

LH over-secretion and reduced fertility characteristics akin to PCOS have also been linked to AMH overexposure, which Joop Laven from Erasmus University in the Netherlands said leads to aberrant wiring of the midbrain. High AMH levels have consequences too for PCOS offspring Laven presented findings showing the hormone impairs aromatase activity in the placenta with LH levels higher in PCOS daughters (and in sons) compared with controls. A possible clinical approach, he suggested, was that PCOS patients delay pregnancy to when embryo yields may be higher and aneuploidy lower.

Inger Sundstrom-Poromaa from Uppsala University Hospital in Sweden cited overwhelming evidence from RCTs for selective serotonin reuptake inhibitors (SSRIs) as a first line therapy for premenstrual dysphoric disorder (PMDD). She also highlighted the pros and cons of other treatments: low dose hormonal contraceptives, GnRH agonists (which alleviate symptoms but have side effects unacceptable to many), progesterone, which Sundstrom-Poromaa concluded is ineffective, and a future novel treatment ulipristal acetate (UA) shown to be effective in curing PMDD symptoms (50% UA group vs 22% placebo) but which cant currently be prescribed following an EMA review.(1)

Despite a 60-year history and widespread worldwide use, the contraceptive pills impact on brain structure via hormone suppression remains underexplored. The 160 Campus participants attending online from 48 countries heard how more (and better designed) longitudinal studies are still needed to establish associations (as suggested in current literature) between the range of progestogens used and brain effects - eg, increased working memory and depression.

During the second half of the meeting, on common fertility-related endocrine conditions, several presenters made lively cases for better treatments. Psychiatrist Vibe Frokjaer from Copenhagen University, Denmark, provided an update on sex hormone fluctuations, mental distress and associations with ART. Research by her and colleagues into women following GnRH agonist and GnRH antagonist protocols for ART suggests that mental distress during treatment is not causally linked to hypogonadism per se or to the choice of protocol.(2) Instead, estrogen sensitivity, brain-based mechanisms and neuroticism appear to play a role, and this needs to be translated into prevention/treatment, she said.

In a presentation on estradiol deficiency, Lawrence Nelson from the Mary Elizabeth Conover Foundation in the US outlined the dramatic consequences of low levels (eg, memory loss and anxiety) and appealed to ESHRE members for wider support of physiologic HRT (with transdermal patches) so women, notably POI patients, get the hormone they were meant to have.(3) Aled Rees, from Cardiff University in Wales, urged clinicians to screen PCOS patients in light of evidence of higher prevalence of emotional distress among these women, and for researchers to adjust for obesity in order to determine its role vs PCOS in psychological symptoms; and an update was given on endometriosis treatments including preliminary findings for publication next year on the role of virtual reality in alleviating chronic pelvic pain.

Campus organiser Cornelis Lambalk said there were many areas still to explore in the field of hormones and the brain, but the ambition is to cover these in a follow-up event next year.

1. Comasco E, Kopp Kallner H, Bixo M, et al. Ulipristal acetate for treatment of premenstrual dysphoric disorder: A proof-of-concept randomized controlled trial. Am J Psychiatr 2020: 178: 256-265. https://doi.org/10.1176/appi.ajp.2020.200302862. Stenbk D, Toftager M, Hjordt L, et al. Mental distress and personality in women undergoing GnRH agonist versus GnRH antagonist protocols for assisted reproductive technology. Hum Reprod 2015; 30; 103-110. https://doi.org/10.1093/humrep/deu2943. Vinogradova Y, Coupland C, Hippisley-Cox J. Use of hormone replacement therapy and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases. BMJ 2019; 364; doi:10.1136/bmj.k4810

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The many effects of reproductive hormones on the brain - ESHRE

Hormone Replacement Therapy (HRT) Market to Eyewitness Stunning Growth by 2027 Covid-19 Analysis The Shotcaller – The Shotcaller

Market share, size, participants, growth and industry analysis are some of the prominent factors covered in this Hormone Replacement Therapy (HRT) market report. This comprehensive report starts with a goal to give information about market forecast, channel features, end-user market, key pricing structure and different geographies. Besides talking about this, it further mentions key regions, key companies along with their profiles and investment options available in the market. Hormone Replacement Therapy (HRT) market is anticipated to grow hugely during the forecasting period 2021-2027. It further proceeds with geographical analysis covering prominent regions such as North America, Europe, Middle East and Latin America.

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The study in this report will aid organizations in understanding the major threats and opportunities that retailers face in the global market. In addition, the study offers an all-around view of the competitive landscape as well as a SWOT analysis. This report contains extensive information on product or technological developments in the global Hormone Replacement Therapy (HRT) market, as well as an overview of the effect of these developments on the markets potential growth.To retain their supremacy in the global Hormone Replacement Therapy (HRT) industry, the majority of companies are currently implementing new technology, strategies, product innovations, expansions, and long-term contracts. Following a review of key companies, the report focuses on the startups that are helping to drive business growth. The reports authors identify possible mergers and acquisitions among startups and key organizations in the study. Key Players are working hard to adopt the latest technology to gain a strategic advantage over the competition as new technologies are introduced on a regular basis.

Major Manufacture:Novartis Pfizer Amgen Novo Nordisk Merck & Co. Bayer Eli Lily Wyeth Mylan Laboratories Abbott Laboratories Genentech

Worldwide Hormone Replacement Therapy (HRT) Market by Application:Menopause Hypothyroidism Male Hypogonadism Growth Hormone Deficiency Others

Worldwide Hormone Replacement Therapy (HRT) Market by Type:Oral Parenteral Transdermal Others

Table of Content1 Report Overview1.1 Product Definition and Scope1.2 PEST (Political, Economic, Social and Technological) Analysis of Hormone Replacement Therapy (HRT) Market2 Market Trends and Competitive Landscape3 Segmentation of Hormone Replacement Therapy (HRT) Market by Types4 Segmentation of Hormone Replacement Therapy (HRT) Market by End-Users5 Market Analysis by Major Regions6 Product Commodity of Hormone Replacement Therapy (HRT) Market in Major Countries7 North America Hormone Replacement Therapy (HRT) Landscape Analysis8 Europe Hormone Replacement Therapy (HRT) Landscape Analysis9 Asia Pacific Hormone Replacement Therapy (HRT) Landscape Analysis10 Latin America, Middle East & Africa Hormone Replacement Therapy (HRT) Landscape Analysis 11 Major Players Profile

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The study takes into account a broad range of market impact factors, as well as potential emerging factors for different Types, End-Users, Regions and also covers the COVID-19 impact on the market; in order to identify the most promising growth patterns in the global industry. The business ability and demand potential of more than 34 major powers are covered in the research for presenting the most promising investment fields in North America, Europe, Asia Pacific, and Latin America, Middle East, and Africa, offering useful opinions on strategic changes for existing groups and new entrants.

In-depth Hormone Replacement Therapy (HRT) Market Report: Intended AudienceHormone Replacement Therapy (HRT) manufacturersDownstream vendors and end-usersTraders, distributors, and resellers of Hormone Replacement Therapy (HRT)Hormone Replacement Therapy (HRT) industry associations and research organizationsProduct managers, Hormone Replacement Therapy (HRT) industry administrator, C-level executives of the industriesMarket Research and consulting firms

Hormone Replacement Therapy (HRT) Report Provide:Potential opportunities and challenges analysis in Hormone Replacement Therapy (HRT) market.Current and future market outlook in the developed and emerging regional markets.Detailed analysis of the segment that is expected to dominate the market.Regions that are expected to witness the fastest growth during the forecast period.Identify the latest developments, market shares, and strategies employed by the major market players.Comprehensive & in-depth research and after-sales warranty by Global Market Monitor.Analysis of Influences of COVID-19 to the present and future Hormone Replacement Therapy (HRT) market and related industry.

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Hormone Replacement Therapy (HRT) Market to Eyewitness Stunning Growth by 2027 Covid-19 Analysis The Shotcaller - The Shotcaller

The Male Hypogonadism Market To Witness Steadfast Growth In The Next 10 Years The Courier – The Courier

The Male Hypogonadism Market report by Persistence Market Research is focusing on the fact that healthcare providers are into collection of socioeconomic information of the patients, so that tracking at any point of time is possible. This on-the-go monitoring is amongst the ongoing trends in the healthcare industry.

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 exceedUS$ 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.

Access Full Report @https://www.persistencemarketresearch.com/checkout/22303

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.

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The Male Hypogonadism Market To Witness Steadfast Growth In The Next 10 Years The Courier - The Courier

The Male Hypogonadism Market To Ride On Innovations KSU | The Sentinel Newspaper – KSU | The Sentinel Newspaper

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

Starting With The New Decade On A Diligent Note In The Male Hypogonadism Market? https://www.persistencemarketresearch.co/methodology/22303

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.

How About Obtaining Insights About The Region To Enter Concerning The Male Hypogonadism Market? Press The Purchase Now Button To Have Our Male Hypogonadism Market Report! https://www.persistencemarketresearch.com/checkout/22303

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.

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Persistence Market Research is here to provide companies a one-stop solution with regards to bettering customer experience. It does engage in gathering appropriate feedback after getting through personalized customer interactions for adding value to customers experience by acting as the missing link between customer relationships and business outcomes. The best possible returns are assured therein.

Contact us:

Persistence Market ResearchAddress 305 Broadway, 7th FloorNew York City,NY 10007 United StatesU.S. Ph. +1-646-568-7751USA-Canada Toll-free +1 800-961-0353Salessales@persistencemarketresearch.comWebsite https://www.persistencemarketresearch.com

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The Male Hypogonadism Market To Ride On Innovations KSU | The Sentinel Newspaper - KSU | The Sentinel Newspaper

Hormone Replacement Therapy Market Global Industry Scope and Growth Analysis Report 2021: Opportunity Assessment, Business Boosting Strategies, and…

The latest research report on Hormone Replacement Therapy Market delivers a comprehensive study on current market trends. The outcome also includes revenue forecasts, statistics, market valuations which illustrate its growth trends and competitive landscape as well as the key players in the business.

Global Hormone Replacement Therapy Market is valued at USD 19.45 Billion in 2019 and expected to reach USD 33.77 Billion by 2026 with the CAGR of 8.2% overtheforecast period

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Hormone replacement therapy is a treatment used to release symptoms of the menopause. The main advantage is that it is a very effective method of controlling menopausal symptoms, and it can make an important difference to a womans quality of life and security. Hormone replacement therapy can also reduce a womans risk of developing osteoporosis and cancer of the colon and rectum. Additionally, hormones are secreted predominantly from the endocrine glands and absorbed into the bloodstream. The hormones that have been most commonly utilised in hormone replacement therapy are progesterone, estrogen, testosterone, adrenal hormones, DHEA, thyroid hormones, pregnenolone, melatonin, and human growth hormone. It is the most effective treatment for menopause symptoms. Systemic hormone replacement therapy helps in treating cancer, rheumatoid arthritis and other diseases. Moreover, this treatment is particularly favorable for patients with growth hormone deficiency, women nearing menopause and elderly people suffering from hypogonadism. It may also protect against osteoporosis.

Global Hormone Replacement Therapy market report is segmented on the basis of product, administration, disease and region & country level. Based upon product, global hormone replacement therapy market is classified into estrogen replacement therapy, human growth hormone replacement therapy, thyroid replacement therapy and testosterone replacement therapy. Based upon administration, the market is divided into oral, parenteral and transdermal. Based upon disease, global hormone replacement therapy market is classified into menopause, hypothyroidism, male hypothyroidism, growth hormone deficiency, cancer and other.

The regions covered in this Hormone Replacement Therapy market report are North America, Europe, Asia-Pacific and Rest of the World. On the basis of country level, market of Hormone Replacement Therapy sub divided into U.S., Mexico, Canada, U.K., France, Germany, Italy, China, Japan, India, South East Asia, GCC, Afria, etc.

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Big Study Found No Rise in Death Risk among Women who Took Hormone Therapy

September 12th, 2017; after a massive study of hormone replacement therapy was halted due to higher rates of breast cancer, heart attack and stroke among women assigned to the drugs to treat menopausal symptoms, a new follow-up study has found those women had no higher risk of death as of 2014 than participants who took a placebo.

The Growing Awareness about Hormone Replacement is the Key Factor Influencing the Global Hormone Replacement Therapy Market Growth.

Increasing healthcare expenditure due to growing awareness about health related problems. For example, According to OECD, the US spent $10,209 on healthcare per capita, or per person, in 2017. Thats more than any other country in OECDs 36-country consortium, and over $2,000 more than Switzerland, the second-highest spending country. In addition, rising drug development and hormonal imbalance disorders with rising geriatric population are also boosting the hormone replacement therapy market growth. Additionally, the rising womens population between the age group of 45 to 60, which increases the range of menopausal window due to this factor the demand of hormonal replacement therapy, is also growing. However, the hormone replacement therapy has number of side effects which may hamper the market growth. For example, fluid retention, indigestion, headache, and depression, bloating, swelling, nausea, leg cramps. Combined hormone replacement therapy slightly increases the risk of developing breast cancer, womb cancer, ovarian cancer and stroke. For example, Women who take hormone replacement therapy for more than 1 year have a higher risk of breast cancer than women who never use hormone replacement therapy. The risk is linked to all types of hormone replacement therapy except vaginal oestrogen. In spite of that, technological advancements in this field may create the number of opportunities within the forecast period.

North America is expected to Dominate the Global Hormone Replacement Therapy Market

North America is expected to dominate the global hormone replacement therapy market due to the increasing awareness about the hormonal replacement therapy And Increasing number of womens which have menopause problems in this region. For example, National Center for Biotechnology Information, in the United States, approximately 1.3 million women become menopausal each year and, 1% of women experience premature menopause before the age of 40. The Asia Pacific is expected to experience surge of demand too, owing to the factors such as increased awareness levels among the end users and improving healthcare infrastructure. Rising geriatric population is one of the primary factors responsible for the growth of the hormonal replacement therapy marketin the Europe.

Key Benefits for Global Hormone Replacement Therapy Market Report-

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Global Hormone Replacement Therapy Market Segmentation:

By Product:

By Administration:

By Disease:

By Regional & Country Analysis:

North America, U.S., Mexico, Canada , Europe, UK, France, Germany, Italy , Asia Pacific, China, Japan, India, Southeast Asia, South America, Brazil, Argentina, Columbia, The Middle East and Africa, GCC, Africa, Rest of Middle East and Africa

Table of Content

1.1. Research Process

1.2. Primary Research

1.3. Secondary Research

1.4. Market Size Estimates

1.5. Data Triangulation

1.6. Forecast Model

1.7. USPs of Report

1.8. Report Description

2.1. Market Introduction

2.2. Executive Summary

2.3. Global Hormone Replacement Therapy Market Classification

2.4. Market Drivers

2.5. Market Restraints

2.6. Market Opportunity

2.7. Hormone Replacement Therapy Market: Trends

2.8. Porters Five Forces Analysis

2.9. Market Attractiveness Analysis

Continued

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Hormone Replacement Therapy Market Global Industry Scope and Growth Analysis Report 2021: Opportunity Assessment, Business Boosting Strategies, and...

Global Hormone Replacement Therapy (HRT) Industry Market Report 2020, Forecast Till 2027 By Type, End-use, Geography and Player The Courier – The…

Global Market Monitor recently published a market research report on Hormone Replacement Therapy (HRT), which studied Hormone Replacement Therapy (HRT) industry outlook, competitive situation, regional market analysis, type & application segment analysis, and market trend forecast by 2027.

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Competition AnalysisMajor enterprises in the global market of Hormone Replacement Therapy (HRT) include:Amgen Novartis Novo Nordisk Wyeth Eli Lily Merck & Co. Abbott Laboratories Mylan Laboratories Bayer Genentech Pfizer

View the Comprehensive Analysis on Various Segment:https://www.globalmarketmonitor.com/reports/656651-hormone-replacement-therapyhrtmarket-report.html

Market Segments by Application:Menopause Hypothyroidism Male Hypogonadism Growth Hormone Deficiency Others

Market Segments by TypeOral Parenteral Transdermal Others

Table of Content1 Report Overview1.1 Product Definition and Scope1.2 PEST (Political, Economic, Social and Technological) Analysis of Hormone Replacement Therapy (HRT) Market2 Market Trends and Competitive Landscape3 Segmentation of Hormone Replacement Therapy (HRT) Market by Types4 Segmentation of Hormone Replacement Therapy (HRT) Market by End-Users5 Market Analysis by Major Regions6 Product Commodity of Hormone Replacement Therapy (HRT) Market in Major Countries7 North America Hormone Replacement Therapy (HRT) Landscape Analysis8 Europe Hormone Replacement Therapy (HRT) Landscape Analysis9 Asia Pacific Hormone Replacement Therapy (HRT) Landscape Analysis10 Latin America, Middle East & Africa Hormone Replacement Therapy (HRT) Landscape Analysis 11 Major Players Profile

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Key Regions OverviewMajor countries of North America, Europe, Asia Pacific, and the rest of the world are all exhaustive analyzed in the report. Apart from this, policy mobilization, social dynamics, development trends, and economic development in these countries are also taken into consideration.

In-depth Hormone Replacement Therapy (HRT) Market Report: Intended AudienceHormone Replacement Therapy (HRT) manufacturersDownstream vendors and end-usersTraders, distributors, and resellers of Hormone Replacement Therapy (HRT)Hormone Replacement Therapy (HRT) industry associations and research organizationsProduct managers, Hormone Replacement Therapy (HRT) industry administrator, C-level executives of the industriesMarket Research and consulting firms

Key questions answered in the reportWhat will the market size and growth rate be in 2026?What segment or region will drive or lead market growth and what are the reasons?How will market drivers, constraints and future opportunities affect market dynamics and subsequent analysis of relevant trends?What key strategies are used by top vendors to increase revenue?

About Global Market MonitorGlobal Market Monitor is a professional modern consulting company, engaged in three major business categories such as market research services, business advisory, technology consulting.We always maintain the win-win spirit, reliable quality and the vision of keeping pace with The Times, to help enterprises achieve revenue growth, cost reduction, and efficiency improvement, and significantly avoid operational risks, to achieve lean growth. Global Market Monitor has provided professional market research, investment consulting, and competitive intelligence services to thousands of organizations, including start-ups, government agencies, banks, research institutes, industry associations, consulting firms, and investment firms.ContactGlobal Market MonitorOne Pierrepont Plaza, 300 Cadman Plaza W, Brooklyn,NY 11201, USAName: Rebecca HallPhone: + 1 (347) 467 7721Email: info@globalmarketmonitor.comWeb Site: https://www.globalmarketmonitor.com

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Global Hormone Replacement Therapy (HRT) Industry Market Report 2020, Forecast Till 2027 By Type, End-use, Geography and Player The Courier - The...

Immunosenescence Profile and Expression of the Aging Biomarker (p16INK4a) in Testicular Cancer Survivors Tr… – UroToday

Testicular cancer is one of the most curable solid malignancies, even in advanced stages. However, the high cure rate among testicular cancer survivors (TCS) is offset by the long-term toxicity of oncologic treatments which include second malignant neoplasms, hypogonadism, pulmonary toxicity, and nephrotoxicity. Compared to the normal population, TCS have an increased risk of dying from circulatory diseases and infections. Such risk is particularly greater in patients who received chemotherapy.1

Elderly people are at high risk of developing cancer and have a decreased ability to control infections. These complications are greatly caused by immunosenescence, the aging process of the immune system. Immunosenescence is characterized by several changes in the lymphocyte subpopulations: there is a decrease in T cells and nave lymphocytes (B and T cells), while CD57+ and CD28- terminally differentiated senescent cells increase. The cell-cycle regulating protein p16INK4a is also a senescence biomarker; its expression in most tissues increases with cellular aging.2

Cytotoxic chemotherapy can induce cellular senescence in normal and cancer cells.3 Therefore, we hypothesized that TCS have premature immunosenescence, which may explain the aforementioned long-term complications. This pilot study aimed to search for lymphocyte senescence surface markers as well as p16INK4a gene expression among TCS who were given chemotherapy.4

Our team conducted a case-control study of TCS matched by age and gender with healthy controls. We included patients with at least threebleomycin, etoposide, and cisplatin (BEP) chemotherapy cycles and no evidence of disease for at least three months. Patients with high-dose chemotherapy were excluded. Peripheral blood mononuclear cells were isolated and lymphocyte subpopulations were analyzed by flow cytometry. B and T cells and their corresponding nave and memory subpopulations were defined according to their surface marker combinations. p16INK4a gene expression in T cells was measured using quantitative polymerase chain reaction.

We found that TCS who had previously received chemotherapeutic agents had statistically significant lower levels of total T cells and CD4+ T cells. Among the CD4+ T lymphocytes, TCS had less nave and increased effector memory cells. Within the CD8+ T lymphocytes, TCS exhibited a decrease in the percentage of nave cells and an increase in CD45RA + CD57+ cells (surface markers related to the later stages of differentiation). Furthermore, we found that there was a statistically significant higher p16INK4a gene expression in TCS as compared to the matched controls. These differences are highlighted in Figure 1.

Figure 1.Immunosenescence profile of testicular cancer survivors (TCS) compared with healthy controls.

Our data suggest that TCS previously treated with chemotherapy may have an immunological phenotype associated with immunosenescence. Potential confounders for these results (like diabetes and hypogonadism) were controlled and excluded. Chemotherapys causal effect, however, remains to be defined. Our study has several limitations, the most important being the cross-sectional nature of it, and we do not know if these alterations persist over time. Future evaluations are necessary to be done in a longitudinal study that allows a patients evaluation at diagnosis, during, and after oncologictreatments.

We believe that further studies are required to help elucidate the clinical implications of the premature immunosenescence in TCS. This is a group of patients that warrants special attention for they receive oncologic treatments at a very young age, and premature immunosenescence may impose many consequences during their lifespan.

Written by: Maria T Bourlon, MD, MSc, Twitter:@BourlonMaite, Francisco J Castro-Alonso, MD, Arturo Carballo, MD, Luis Llorente, MD, Instituto Nacional de Ciencias Mdicas y Nutricin Salvador Zubirn, Mexico City, Mexico

References:

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Immunosenescence Profile and Expression of the Aging Biomarker (p16INK4a) in Testicular Cancer Survivors Tr... - UroToday

Europe to hold The major Piece of Cake in the Anabolic Steroids Market between 2020 and 2030 Jumbo News – Jumbo News

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.

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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.

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.

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Europe to hold The major Piece of Cake in the Anabolic Steroids Market between 2020 and 2030 Jumbo News - Jumbo News

The Male Hypogonadism Market to witness a splendid CAGR in the next decade Murphy’s Hockey Law – Murphy’s Hockey Law

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 exceedUS$ 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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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.

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The Male Hypogonadism Market to witness a splendid CAGR in the next decade Murphy's Hockey Law - Murphy's Hockey Law

Testosterone for Managing Treatment-related Fatigue in Patients With Metastatic Renal Cell Carcinoma: A Pha… – UroToday

Fatigue is one of the most common adverse events of systemic therapy in patients with metastatic renal cell carcinoma (RCC). The aim of multicenter randomized phase 2 study was to determine the efficacy and safety of testosterone in patients with fatigue developed during targeted therapy.

Male patients with metastatic clear-cell RCC, normal prostate-specific antigen level, low testosterone level, and no evidence of hypothyroidism receiving first-line sunitinib or pazopanib with fatigue were randomly assigned (1:1) to either testosterone undecanoate (1000mg) and targeted therapy or targeted therapy alone. The primary endpoint was the mean change of fatigue from baseline to 28 days according to the Functional Assessment of Chronic Illness Therapy-Fatigue scale. Secondary endpoints were safety, Functional Assessment of Cancer Therapy-Kidney Symptom Index 19, testosterone serum concentrations, red blood cell count, and hemoglobin level.

Sixty patients were assigned to receive testosterone and targeted therapy (N=30) or targeted therapy alone (N=30). As of the data cutoff on December 30, 2019, median follow-up was 18.2 months. The study achieved its primary endpoint based on the significant differences at day 28 favoring testosterone over targeted therapy alone regarding the decreased level of fatigue (difference between groups, 22.5 points; 95% confidence interval, 18.4-26.6; P=0.012). Significant changes in scores demonstrating the enhanced quality of life with testosterone compared with targeted therapy were also observed for Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 disease-related symptoms (P=0.01). There were nonsignificant differences in red blood cell count and hemoglobin level between the 2 groups (all P>0.05).

Male patients with metastatic RCC and hypogonadism receiving testosterone had less fatigue and better symptom control during targeted therapy.

American journal of clinical oncology. 2021 Jan 27 [Epub ahead of print]

Ilya Tsimafeyeu, Yulia Tishova, Ruslan Zukov, Pavel Borisov, Anastasia Bondarenko, Kristina Zakurdaeva

Kidney Cancer Research Bureau Institute of Oncology, Hadassah Medical Moscow RUDN University I.M. Sechenov First Moscow State Medical University RakFond, Moscow V.F. Voino-Yasenetsky Krasnoyarsk State Medical University, Krasnoyarsk City Clinical Oncology Center, St. Petersburg, Russia.

PubMed http://www.ncbi.nlm.nih.gov/pubmed/33512910

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Testosterone for Managing Treatment-related Fatigue in Patients With Metastatic Renal Cell Carcinoma: A Pha... - UroToday

Marius Pharmaceuticals Announces Co-CEOs Himanshu H. Shah and Shalin Shah to Drive Growth ahead of Anticipated FDA Action of its Lead Asset, KYZATREX…

RALEIGH, N.C., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a specialty pharmaceutical company focusing on treating conditions that are primarily associated with testosterone deficiency, today announced that it has appointed Himanshu H. Shah and Shalin Shah as co-CEOs to drive the next phase of growth as the company looks to a potential launch of KYZATREX in Q4 2021 and further the development of Marius deep clinical pipeline.

Himanshu H. Shah brings over 30 years of experience across global capital markets and will continue his role as chairman of the board in addition to co-CEO. He has advised numerous public and private companies over the past decades to help them unlock substantial shareholder value and execute both innovative and pragmatic business strategies.

I am proud to continue serving Marius and work on developing the best treatment options for men with hypogonadism, a common but not widely discussed disease among patients and prescribers, said Himanshu H. Shah, chairman and co-CEO of Marius Pharmaceuticals. Misconceptions about hypogonadism are having a huge impact on the health of millions of men globally and costing the U.S. healthcare system alone billions of dollars annually. There is a huge opportunity for Marius to address these issues and drastically alter the testosterone therapy landscape.

Shalin Shah will also step into the role of co-CEO from chief financial officer and executive vice president of strategy for Marius. Shalin has been integral in driving overall strategy at Marius for the past four years and will oversee the growth of the team and execution of innovative models as it expands both clinically and commercially to become a leading pharmaceutical company.

I am excited for the opportunity to serve Marius in this new capacity, especially at a time when the world is seeing technology and healthcare intersect more than ever, truly helping patients, said Shalin Shah, co-CEO of Marius Pharmaceuticals. I am confident in Marius mission to better the lives of patients by ensuring adequate levels of testosterone and enhance patient care through disruptive technologies and personalization.

Om Dhingra, Ph.D., led the company from initial development of the lead compound through two successful Phase 3 clinical trials and will move into the role of vice chairman. He will help guide the companys clinical development plan and ensure KYZATREX and its differentiating safety and efficacy data is well known in the medical world.

It has been my great pleasure serving the company as CEO. I am very proud of the data we have generated, which we believe will position KYZATREX as the standard of care for patients suffering from hypogonadism globally, said Dr. Om Dhingra, vice chairman of Marius Pharmaceuticals.

If approved by the FDA, KYZATREX has the potential to become the new standard of care for treating patients with hypogonadism. Testosterone is a crucial hormone that is essential to sexual and reproductive health, but also has important functions in metabolic, inflammatory, cardiovascular and neurological health. In the U.S. there are at least six million symptomatic men suffering from hypogonadism, and over 100 million men globally. The resulting medical costs associated with men with untreated hypogonadism and related comorbidities are more than $25 billion in the U.S. alone. Current treatments on the market are dominated by therapies with unappealing administration methods, including auto-injections, in-office infusions and topical gels and creams that have a high transference risk. KYZATREX is an orally administered treatment that avoids the drawbacks that keep men from continuing treatment on available testosterone therapies.

About KYZATREX KYZATREX if approved, will represent a novel oral testosterone replacement therapy option for adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

The ReTUNE study was a multi-center, 12-month study across the U.S. that studied the safety and efficacy of KYZATREX in hypogonadal subjects (total testosterone 281 ng/dL). Efficacy was determined by number of subjects in the normal, eugonadal range after 90 days of treatment, including dose titrations, while safety was monitored for a further 9 months while on a steady dose. In addition to testosterone parameters, the study collected Patient Reported Outcomes (PROs), which showed statistically significant results both from baseline and against its comparator. A pivotal six-month Phase 3 study was conducted, in which subjects were monitored using ABPM, now considered the standard BP assessment by the FDA and clinical experts. An improved dose regimen was also used in the pivotal six-month Phase 3 study. The results of the Phase 3 studies will be published in leading medical journals and presented at national conferences in 2021.

The FDA has conditionally accepted KYZATREX as the trade name for this investigational drug. The safety and efficacy have not been fully evaluated by any regulatory authority.

About Marius PharmaceuticalsMarius is a specialty pharmaceutical company focusing on treating conditions that are primarily associated with hypogonadism, commonly referred to as testosterone deficiency. The companys mission is to improve the functional lives of patients and reduce the risks of the downstream effects of endocrine imbalance by ensuring appropriate level of testosterone. For more information, please visit http://www.mariuspharma.com.

Media Contact: Emily Brice919-610-3319ebrice@fwv-us.com

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/f825d70b-874a-4cef-9160-429f83bbfc66

https://www.globenewswire.com/NewsRoom/AttachmentNg/ba2569ca-0922-4b49-8d68-49424b5e44d4

Himanshu H. Shah

Co-CEO and Chairman of the Board, Marius Pharmaceuticals

Shalin Shah

Co-CEO, Marius Pharmaceuticals

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Marius Pharmaceuticals Announces Co-CEOs Himanshu H. Shah and Shalin Shah to Drive Growth ahead of Anticipated FDA Action of its Lead Asset, KYZATREX...

Male Hormone Replacement Therapy And The Side Effects – Nerd’s Magazine

Testosterone replacement therapy is done to restore the testosterone levels in men. It is referred to ashormone replacementtherapy. Testosterone is a hormone in men that is produced in the testicles and helps to maintain sex drive, bone density, facial and body hair, sperm production, fat distribution, and red blood cells production. Testosterone levels are highest during adolescence and early stages of adulthood. The levels decline gradually as men age at around 30-40 years.

Testosterone in men may decline due to two reasons. First, it may be due to health conditions that have an effect on the testicles eg cancer, infection, and injury. The disease that results from low levels of testosterone is called hypogonadism. This condition prevents testosterone production by affecting the testicles and pituitary glands. Secondly, it may be as a result of natural decline as a man ages i.e. when men reach 30, they may start experiencing testosterone reduction. Low testosterone levels are considered normal but to some men, it may be extremely abnormal levels hence require replacement.

Decline testosterone levels can lead to symptoms such as reduced sexual desire with few erections that happen spontaneously, physical changes such as decreased muscle strength and mass, increased body fat, swollen and tender breasts, hair loss, fatigue, osteoporosis, emotional changes that lead to reduced motivation and self-esteem eg depression, and infertility. These symptoms can be a result of the side effects of the therapy, thyroid problems, diabetes, and obstructive sleep apnea. Hormone replacement therapy is administered to reverse the lowered testosterone levels in men. The therapy can be recommended to various people with the problem. Both healthy and aging men without hypogonadism diagnosis can be prescribed for testosterone replenishment on showing symptoms. Very high levels of testosterone on the other hand can also cause side effects such as the risk of stroke, infertility, enlarged breasts, and enlarged prostate.

There are several ways in which testosterone replacement can be administered. Testosterone can be taken in gels, intramuscular injections, patches, and topical creams. The method used for administration depends on ones lifestyle and the type of medical need. It can also be taken orally while being monitored to prevent it from being too high. Hormone replacement therapy is meant to induce and maintain secondary characteristics and to correct the symptoms and side effects arising due to low testosterone levels. Testosterone therapy can have some effects when used to prevent normal aging. It worsens sleep obstruction a disorder that causes abrupt stop and start of breathing, promotion of prostate cancer growth, stimulated overproduction of red blood cells increasing blood clotting risks, and reduction in sperm production or testicle shrinkage.

Hypogonadism can be diagnosed as primary or secondary hypogonadism. Abnormalities in testicular levels should be diagnosed, treated, and monitored. Hypogonadism causes testis failure hence reduced production of testosterone concentration and affect the normal number of spermatozoa. It can result from either defect that causes a change in the testis or the hypothalamus. Primary hypogonadism is a result of low T levels, raised gonadotropin levels, or impaired spermatogenesis. Causes of primary hypogonadism include trauma, HIV infection, cancer chemotherapy, myotonic dystrophy, testes exposure to radiation, and infectious orchitis. Secondary hypogonadism is due to low T levels, low or unsuitably normal gonadotropin levels, and spermatogenesis impairment. It is caused by severe obesity, androgenic anabolic steroid withdrawal, hypothalamic tumours, pituitary tumour, and surgery and deprivation therapy of androgen with gonadotropin.

Before testosterone therapy is administered, the clinicians discuss the potential risks and the need for monitoring. Urological evaluation is necessary for men with prostate nodule or induration. In older men, testosterone therapy has a life expectancy of up to 10 years and above. The therapy may lead to side effects and risks such as prostate cancer risk and require prostate monitoring. Some of the symptoms that are evident during T administration include.

Acne and oily skin

Reduced sperm production and fertility

Detection of subclinical cancer

Erythrocytosis

Metastatic prostate cancer growth

Male pattern balding

Breast cancer growth

Obstructive sleep apnea

Heart attack and heart disease

Before settling for testosterone therapy, it is important to take a few cations and think about all the aspects of the therapy. First, analyzing ones health history is key.it is advisable to first consider any other reasons that may be causing the symptoms that are similar to those of low testosterone levels. Sex dysfunctions can also be due to psychological or relationship issues. Cardiovascular disease can also be the reason behind erectile dysfunction. Several clinical measurements may be required to fully diagnose low testosterone levels. The tests are done on varied days and detailed interpretation is needed to establish the amounts of available testosterone. It is also necessary to have information on the possible risks and effects of the therapy and the side effects of the different methods used in administering testosterone.

Baseline evaluation before T administration is done helps to identify and exclude those prone to prostate cancer or who have a high risk of developing prostate cancer. Screening and monitoring in the case of cancer risk require patient and doctor agreement and patient awareness. Factors that should be considered during the baseline assessment are age, race, family history, and prostate examination results. Patient administered with T therapy requires frequent monitoring and assessment to establish whether the therapy is working and in case there are any adverse effects, and that they are responding to the treatment regimen. During the first 12 months of T treatment, it is advisable to get urological consultation to identify ant abnormalities.

Testosterone decline can be due to aging or medical conditions. The treatment and restoration of the levels of testosterone are referred to as testosterone replacement therapy. This therapy requires diagnosis, treatment, and constant monitoring. This is because the therapy treatment has different side effects and risks that vary from one patient to another. A qualified specialist team atLiv Naturalhelps by providing solutions to testosterone deficiency and solve any other health problems that result from low testosterone levels such as erectile dysfunction, low libido, and low muscle mass. Low T levels can only be determined by a diagnosis administered by clinicians i.e. testosterone level test.

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Male Hormone Replacement Therapy And The Side Effects - Nerd's Magazine

New York Medical and Life Sciences: Year in Review 2020 – JD Supra

From contraceptives to mesh implants, shampoos to pasta, New York state and federal courts issued decisions in 2020 which further shaped the landscape in the medical and life sciences legal world. To prepare the best product liability and class action defense strategies for pharmaceuticals, medical devices and other FDA regulated products, it is often helpful to step back and review holdings that have affected the industry and may shape the year ahead.

In the New York Medical and Life Sciences: Year in Review 2020, we review, analyze and share potential implications for future life science cases, based on several key judicial holdings in New York in 2020 pertaining to:

In Re: Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II), 982 F.3d 113 (2d Cir. 2020)

In an appeal from a judgment of the United States District Court for the Southern District of New York granting summary judgment in favor of Bayer dismissing mass tort plaintiffs' products liability Mirena claims after preclusion of the opinions of all of plaintiffs expert witnesses on general causation, the Second Circuit affirmed. Plaintiffs argued that the district court abused its discretion by (1) focusing on plaintiffs' experts' conclusions rather than their methodologies, (2) requiring the experts to back their opinions with published studies that definitively supported their conclusions, and (3) taking a "hard look" at the experts' methodology. The Second Circuit held that plaintiffs may challenge whether the district courts reliability analysis was correct, but plaintiffs had no basis to argue that the district court did not engage in a detailed analysis of their experts' methodologies. An expert need not back his/her opinion with published studies that support his/her conclusion if he/she has utilized reliable scientific methods to reach that conclusion. But here, because the district court found that plaintiffs' experts did not otherwise reliably utilize scientific methods and the conclusions were not supported by other studies, the experts' reports were properly excluded. Not only was it appropriate for the district court to take a hard look at plaintiffs' experts' reports, the court was required to do so to ensure reliability. Plaintiffs also argued that the district court erred in precluding differential-diagnosis evidence, which they argued would have shown general causation. While the Second Circuit declined to adopt a bright-line rule that "a differential diagnosis may never provide a sufficient basis for an opinion as to general causation," they explained that the district judge had broad discretion in determining whether in a given case a differential diagnosis is enough by itself to support such an opinion. And here it was not.

English v Bayer, 468 F. Supp.3d 573 (W.D.N.Y. 2020)

Plaintiffs, three former users of Essure, a Class III medical device contraceptive implant, subject to Pre-Market Approval procedures, and granted PMA by the FDA, asserted causes of action for negligent training of physicians, breach of express warranty and negligent misrepresentation (advertising concerning safety and effectiveness at preventing pregnancy, and qualifications of implanting physicians), negligent risk management (failing to report adverse events to the FDA), and negligent failure to warn. Defendants moved pre-Answer to dismiss under FRCP 12(b)(6) on the basis that plaintiffs claims were entirely preempted by the Medical Device Amendments to the federal Food Drug and Cosmetic Act. The court found plaintiffs did not plausibly allege that the FDA-approved training requirements placed any duty on defendants to do so. To the extent that plaintiffs claimed that defendants did deviate from FDA-approved training requirements by failing to ensure that implanting physicians completed preceptoring requirements, read and understood the Physician Training Manual, and successfully completed simulator training, those claims did not seek to impose obligations beyond those mandated by the FDA, and thus arguably were not expressly preempted. However, they were nonetheless impliedly preempted since plaintiffs did not plead any parallel state law cause of action that supported their negligent training claims, nor did their opposition identify any New York law establishing liability on the part of a non-employer for injuries to third parties arising out of alleged negligent training. With respect to plaintiffs failure to report adverse events to the FDA claims, even if they were characterized as a failure to warn, they were expressly preempted: plaintiffs could not maintain a claim that defendants were required to issue additional warnings beyond what the FDA prescribed and approved. Furthermore, as a standalone claim, failure to report adverse events to the FDA is not a cognizable cause of action under New York law.

Montero v. Teva Pharmaceuticals USA Inc. et al., No. 19 Civ. 9304, 2020 WL 1862593 (S.D.N.Y. April 14, 2020)

Plaintiff alleged that she developed blood-clots, resulting in a pulmonary embolism, as a result of using an oral contraceptive, marketed as a generic drug. The complaint asserted causes of action for negligence, strict liability, breach of warranty, fraud and negligent misrepresentation. On a FRCP 12(c) motion for judgment on the pleadings, the court dismissed the warning and design claims as preempted, citing Supreme Court precedents (PLIVA, Inc. v. Mensing 564 U.S. 604 (2011) and Mut. Pharm. Co. v. Bartlett, 570 U.S. 472 (2013)). Moreover, plaintiff could not proceed on her other claims, including a failure to test theory, a theory premised on the suggestion that such testing would have shown that the oral contraceptive was too dangerous for the market. That argument is inconsistent with Bartlett, which held that the stop-selling rationale that products should be pulled from the market is incompatible with preemption jurisprudence because preemption cases presume that an actor seeking to satisfy both his federal and state law obligations is not required to cease acting altogether in order to avoid liability.

Contraceptives Potential implication for future cases: In contraceptive product liability actions, whether the product is regulated as a drug or a device, preemption remains a first line of defense. Even non-traditional theories, such as failure to test, train or report AERs, are vulnerable to dismissal. New York continues to be wary of admitting differential diagnosis expert opinion on issues of general causation.

Balura v Ethicon, No. 3:19-CV-1372, 2020 WL 819293 (N.D.N.Y. Feb. 19, 2020)

In a massive products liability multi-district litigation involving transvaginal surgical mesh used primarily to treat pelvic organ prolapse and stress urinary incontinence, defendants moved to exclude a specific causation expert alleging differential diagnosis, as the opinion was replete with factual errors, which prohibited him from forming a proper foundation for his opinions. The court ruled that the differential diagnosis opinion was suitable in a specific causation analysis. However, the opinion that plaintiffs pelvic injuries were caused by a defective device without specifying any design defect was insufficient under New York law. The court ruled the expert failed to describe or explain how a defect in the mesh caused plaintiffs injuries, as opposed to the mere presence of the mesh itself. Finally, the experts opinions about alleged future complications were speculative and unreliable, as not consistent with Dauberts methodology requirements.

Arruda v. C.R. Bard, No. 6:19-cv-1523, 2020 WL 4569436 (N.D.N.Y. Aug. 6, 2020)

In a product liability matter involving Align, a 510K device, defendant contended that plaintiff could not prevail on a design defect claim unless she also demonstrated a failure to warn. Defendant argued that a medical device that is implanted and requires a prescription is a Comment K unavoidably unsafe product to which strict products liability would not normally apply. Defendant, however, largely relied on cases that involved prescription drugs, not devices. The court noted the Second Circuit would assess the viability of a design defect claim under the legal standard for such claims in New York a utility/risk analysisrather than by applying the unavoidably unsafe products exception. The court thus did not require plaintiff to show a failure to warn in order to maintain a design defect claim. Defendants attempt to have the court adopt a categorical approach to the exception stated in Comment K, finding that any medical device implanted pursuant to a prescription is unavoidably unsafe, was rejected. Among other things, the court denied defendants motion for summary judgment on design defect and failure to warn claims.

Dunham v. Covidien, 19-cv-2855, 2020 WL 5995102 (S.D.N.Y. Oct. 9, 2020) and Krulewich v Covidien, No. 19-cv-2857, 2020 WL 5995103 (S.D.N.Y. Oct. 9, 2020)

In a Covidien mesh action, defendant moved to dismiss claims for common law strict products liability (manufacturing defect, design defect, and failure to warn), negligence, breach of warranty (express and implied), negligent and fraudulent misrepresentation, unconscionable commercial practices under New York General Business Law Sections 349 and 350, unjust enrichment, and punitive damages, which was granted. Dunham v. Covidien. On the same day, the same court dismissed claims for common law strict products liability (manufacturing defect, design defect, and failure to warn), negligence, breach of warranty (express and implied), negligent and fraudulent misrepresentation, unconscionable commercial practices under New York General Business Law Sections 349 and 350, unjust enrichment, punitive damages, and loss of consortium. Krulewich v Covidien. In both cases, plaintiffs proposed alternative design was to use polypropylene instead of polyester. Plaintiffs did not adequately plead that the use of polyester was a substantial factor in causing the injuries. The plaintiffs thus failed to allege adequately a design defect claim. The court also found deficiencies in the plaintiffs failure to warn claims because the allegations did not identify how the warnings given were insufficient to warn physicians and the plaintiffs of the potential dangers of using the mesh. The warnings provided noted the risks of the complications that plaintiff actually experienced, namely, chronic pain, adhesion, and hernia recurrence.

Surgical MeshPotential implication for future cases: Surgical mesh plaintiffs must adequately plead their design defect and warning claims under traditional New York concepts of product liability. New York approaches design defect for a medical device under a risk utility balancing approach, not as an unavoidably unsafe product. Plaintiffs must specify the design defect through expert witness opinion evidence.

Gayle v. Pfizer, Inc., 452 F. Supp.3d 78 (S.D.N.Y. 2020).

24 plaintiffs claimed the cholesterol drug Lipitor caused their type II diabetes. Pfizer moved for judgment on the pleadings under FRCP 12(c) on the basis that if the claims arose after the 2012 Lipitor label change, they were preempted and if the claims arose before April 2016 they were time-barred. The court found the claims preempted, even though plaintiffs theorized 6,000 adverse event reports relating to diabetes from Pfizer to the FDA constituted newly acquired information which would enable the manufacturer to change the label under the FDAs Changes Being Effected (CBE) regulations. In order to qualify as "newly acquired information," the information must demonstrate "reasonable evidence of a causal association with a drug" 21 C.F.R. 201.57. But the fact that a user of a drug has suffered an adverse event, standing alone, does not mean that the drug caused that event. Additionally, while plaintiffs did not allege when their claims accrued, to the extent they accrued before April 2016, they were deemed untimely. Applying New Yorks borrowing statute CPLR 202 (which applies the shorter of the New York or other state statute of limitations) the court found the claims untimely. Plaintiffs could not take advantage of New Yorks discovery rule allowing plaintiffs to bring a claim one year after discovery of the cause of the injuries, because plaintiffs would still be caught in the preemption trap. Plaintiffs did not plead that technical, scientific or medical knowledge and information sufficient to ascertain the cause of their injury had not been discovered. Nor did plaintiffs plead with particularity that Pfizer fraudulently concealed the information, to equitably toll the statute of limitations.

Potential implication for future cases: Adverse event reports are not evidence of causation, and do not enable plaintiffs to do an end-run around preemption.

Vardouniotis v. Pfizer, 2020 NY Slip Op 32233(U) (Sup. Ct., NY County 2020)

In a state court action involving Chantix, a smoking cessation medication manufactured by Pfizer, defendant moved, pursuant to CPLR 3211(a)(7), to dismiss the verified complaint. The court dismissed the negligence, gross negligence, and willful, wanton and malicious conduct claims insofar as those causes of action were based upon failure to warn allegations, as well as the breach of express warranty, fraudulent misrepresentation, fraudulent concealment, reckless and/or negligent misrepresentation and concealment claims, and the plaintiffs request for punitive damages. Plaintiff argued that the label for Chantix did not include warnings for dystonia, muscular spasm, movement disorders and abnormal posture, which are typically due to neurological disease or a side effect of drug therapy. According to the plaintiff, Pfizer knew or should have known of these side effects, citing newspaper articles and scientific journal publications identifying adverse effects, especially those experienced by the plaintiff, not identified in the Chantix label. Although plaintiff cited newspaper articles and journal articles in her memorandum of law, these articles were not annexed to the complaint or her opposition to Pfizers motion to dismiss. The court declined to take Judicial Notice of facts alluded to, as that is reserved for matter[s] of common and general knowledge, well-established and authoritatively settled. Prince, Richardson on Evidence 2-201 (Farrell 11th ed). There was no showing that these websites were of sufficient authenticity and reliability. Plaintiff also alleged negligence, gross negligence and that Pfizer was wanton and malicious in its actions, misrepresentations, and omissions as a result of Pfizers failure to adequately test Chantix and failure to conduct post-marketing surveillance. Pfizers motion seeking dismissal of these claims was denied. Breach of express warranty was dismissed as no express warranties were pled or presented but the plaintiff adequately alleged that Pfizer breached the implied warranties of merchantability and fitness by holding Chantix out as reasonably fit and suitable when it was allegedly unreasonably dangerous. Unjust enrichment was not duplicative of any other claim, given that plaintiff sought disgorgement of Pfizers profits and monetary benefits. It is well-settled that conduct warranting an award of punitive damages need not be intentionally harmful but may consist of actions which constitute willful or wanton negligence or recklessness. Home Ins. Co. v American Home Prods. Corp., 75 NY2d 196, 204 (1990). Here, the complaint failed to allege that Pfizer engaged in any morally culpable conduct and plaintiffs request for punitive damages was denied.

Potential implication for future cases: New York State courts require that plaintiffs plead their complaints with particularity or be subject to early dismissal of claims not supported. AERs are not facts of which courts will take as Judicial Notice.

Crespo v Merck, No. 13-cv-2388, 2020 WL 5369045 (E.D.N.Y. Sep. 8, 2020), reconsideration denied 2020 U.S. Dist. LEXIS 188955 (E.D.N.Y., Oct. 12, 2020), appeal filed (Jan. 7, 2021)

Plaintiffs pro se brought this products liability action in the District of New Jersey. The Judicial Panel on Multidistrict Litigation transferred it to New York for coordinated pretrial proceedings, pursuant to 28 U.S.C. 1407. Plaintiff alleged sexual dysfunction from use of Propecia, was diagnosed with erectile dysfunction in 2003, and was diagnosed with hypogonadism in Florida, in 2009. At some point in 2009, his doctors discussed the possibility that plaintiffs use of Propecia had caused his sexual dysfunction. Merck moved for summary judgment on the basis of time bar, as plaintiffs filed the action on April 2, 2013. Generally, [a] federal court sitting in diversity jurisdiction applies the choice of law rules of the forum state. Forest Park Pictures v. Universal Television Network, Inc., 683 F.3d 424, 433 (2d Cir. 2012). When the JPML transfers a case, however, the transferee court applies the substantive state law, including choice-of-law rules, of the jurisdiction in which the action was filed. Menowitz v. Brown, 991 F.2d 36, 40 (2d Cir. 1993). The court applied New Jerseys choice-of-law rules, not the rules in New York. Here, two states had a potential interest in this action. New Jersey was the state in which plaintiffs filed the action, and the state in which defendants were incorporated, had their principal place of business, and made decisions regarding the labeling and marketing of Propecia. Florida was the state in which plaintiff was prescribed, purchased, and took Propecia. Plaintiff choose to file suit in New Jersey and there were no exceptional circumstance to justify departing from the general rule that New Jerseys statute of limitations applied, which barred plaintiffs claims.

Potential implication for future cases: In MDL cases, choice of law is not necessarily the law of the forum state, or the plaintiffs residence. Plaintiffs choice of forum may dictate choice of law.

Webb v Mentor, 453 F. Supp.3d 550 (N.D.N.Y. 2020)

MemoryGel silicone breast implants are Class III medical devices, approved by the FDA through the PMA process in 2006. Plaintiff sued in product liability (negligence based on failure to warn and manufacturing defect, negligence per se, strict liability in design and manufacturing defect, breach of express and implied warranty) and asserted claims related to the implants safety and effectiveness. Defendants moved to dismiss the complaint, asserting that plaintiffs claims were preempted, pursuant to the Medical Device Amendments of 1976, 21 USC 360c and, alternatively, that plaintiff failed to state any claims upon which relief may be granted, under FRCP 12(b)(6). To succeed in asserting a claim that fits through the narrow gap between express and implied preemption, plaintiff must identify a parallel law upon which she has based her state law claims. Plaintiff alleged that defendants did not comply with the FDAs Quality System Regulations and Current Good Manufacturing Practices (CGMPs). However, plaintiff failed to identify specific regulations or explain how defendants violated the CGMPs. Plaintiffs general allegations could not withstand preemption because she failed to establish the necessary link between defendants federal violations and her alleged causes of action. Plaintiffs failure to warn and design defect claims were preempted because she sought to impose safety related requirements on the device or labeling beyond those imposed by the FDA. Plaintiffs express and implied warranty claims were preempted; plaintiff did not identify specific representations of the manufacture which exceeded the scope of FDA approved labeling statements nor did she show defendants alleged federal violations caused the implants to have a deviated from their purpose, that they failed, or that they were unfit for patients.

Potential implication for future cases: PMA medical devices, including breast implants, continue to enjoy preemption in New York.

Berni v Barilla, 964 F.3d 141 (2d Cir. 2020)

Plaintiffs brought a class action against Barilla for deceptive packaging, alleging that Barilla intentionally sold its pasta in misleading boxes which concealed non-functional slack-fill, asserting claims under New York General Business Law section 349. The Second Circuit held future harm to pasta purchasers is not likely, and as a result, the injunctive relief sought would not provide a remedy for all members of the class. Pasta purchasers who alleged they were deceived were alleging past harm. Such past harm is of the kind that is commonly redressable at law through the award of damages, not injunctive relief. The district court did, in fact, err in certifying a Rule 23(b)(2) class because not all class members stand to benefit from injunctive relief, the kind of relief the settlement primarily provides. The Second Circuit held that past purchasers of a productlike the purchasers of Barilla pasta in this casewere not eligible for class certification under FRCP Rule 23(b)(2).

Sibrian v Cento Fine Foods, Inc., No. 19-CV-0974, 2020 WL 3618953 (E.D.N.Y. July 2, 2020)

Plaintiffs alleged misleading labeling of canned tomato products from Italy labeled Certified San Marzano under New York General Business Law sections 349 and 350. The court dismissed these claims as conclusory and strained, as the reasonable consumer would not have an expectation that a San Marzano tomato must be certified by the Consortium of the San Marzano Tomato Protected Designation of Origin. Plaintiffs did not allege that Cento falsely claimed the product was certified by the Consortium, and Consortium-certified seals did not appear on the product labels. Rather, plaintiffs contended the labeling and packaging created the impression of that certification. While there might be a few consumers who expect a San Marzano tomato to be certified by the Consortium, drawing upon common sense and common experience, the vast majority of reasonable consumers expect no such thing.

Steele v Wegmans, No. 19 Civ. 9227, 2020 WL 3975461 (S.D.N.Y. July 14, 2020)

Plaintiffs claimed deceptive acts or practices in violation of federal, New York, and Pennsylvania statutes and standards, false advertising, common-law negligent misrepresentation, fraud, breach of warranty and unjust enrichment alleging they were deceived into believing Wegmans ice cream was flavored with vanilla beans or extract. Upon a motion to dismiss, the court found the label on the ice cream container did not misrepresent the container's contents and the plaintiffs elaborate gas chromatography-mass spectrometry analysis chemists performed failed to show there was fraudulently little vanilla bean extract in the ice cream. Similarly in a case involving vanilla almond milk the SDNY found the term vanilla by itself does not communicate to a reasonable consumer that the product was made exclusively with vanilla bean and a reasonable consumer would understand vanilla refers to a flavor, not an ingredient. Cosgrove et al. v. Blue Diamond Growers, No. 19-Civ-8993 (S.D.N.Y. December 7, 2020).

Price v LOral, No. 17 Civ. 614, 2020 WL 4937464 (S.D.N.Y. Aug. 24, 2020)

After certification of two classes of New York and California consumer fraud plaintiffs who claimed they were deceived into purchasing Matrix Biolage Advanced line of Keratin shampoos and conditioners because they contained Keratin, defendants LOral and Matrix moved to exclude plaintiffs experts and both sides moved for summary judgment. The motion to exclude plaintiffs marketing expert opinion on consumer perceptions was granted in part and the economic expert opinion on class-wide damages was excluded as unreliable. Except for the breach of contract claim dismissed under New York law, the summary judgment motions were denied.

Devane v. LOral, No. 19 Civ. 4362, 2020 WL 5518484 (S.D.N.Y. Sept. 16, 2020)

Purported class action plaintiffs alleged LOral deceptively marketed and labeled Eversleek Keratin Caring products to make consumers believe the shampoos and conditioners contained Keratin, even though the products were labeled as vegan and Keratin was not on the ingredient list. Upon a motion to dismiss fraud, warranty and consumer fraud statutory claims (Alabama, Florida and New York), the court analyzed the claims under the reasonable consumer standard. The Second Circuit has noted it is not reasonable to assume that a product contains an ingredient when it is not on the ingredient list. As the product label was clear that the shampoos and conditioners cared for Keratin already found in hair and Keratin was not a listed ingredient, the court dismissed the entire case as not plausible.

Class ActionsPotential implication for future cases: Federal courts in New York scrutinize purported class actions involving FDA-regulated products for plausibility and expert support. The reasonable consumer, drawing on common sense and common experience, does not assume a product contains an ingredient not listed on the label.

The developments of 2020 indicate that it is critical to remain informed about changes in the law in order to develop the strongest product liability defense of pharmaceuticals and medical devices. We know it takes an enormous investment to develop innovative pharmaceuticals and medical devices to improve life experiences. Thats why our attorneys, with a national reputation for aggressively defending some of the largest entities in the regulated pharmaceutical, medical device, cosmetics and nutritional supplement industries, leverage their combination of medical and legal credentials to protect your critical life sciences products.

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New York Medical and Life Sciences: Year in Review 2020 - JD Supra

Male menopause: symptoms, diagnosis and treatment – Netdoctor

We've all heard of the menopause, when a woman's reproductive function starts to slow down but do men experience something similar? The term 'male menopause' refers to the physical and emotional changes that some men experience as they get older. It's a surprisingly controversial topic and experts are divided on the subject, with many disagreeing on what it is, how is should be defined, and if it even exists.

But while debate rages on about what to call this life stage, if you're a man in your late forties or older and you experience worrying symptoms including erectile dysfunction, a loss of sex drive, depression, or fatigue, it is worth getting checked out.

We spoke to nutritionist and male hormone expert Roberta Stringer, co-founder of testosterone health brand DNA, and Dr Luke Pratsides, lead GP at Numan, about the male menopause symptoms, causes and treatment options:

The male menopause, also known as andropause or colloquially as 'manopause' is a term used to describe a cluster of symptoms associated with an age-related decline in testosterone. Despite the name, male menopause differs substantially from female menopause.

Unlike the hormonal drop that occurs in women during this time, sex hormones tend to decrease more gradually in men. Not every man will experience andropause whereas all women experience menopause and men can still reproduce, while women can no longer become pregnant naturally.

'Male menopause is the gradual reduction of testosterone specifically related to ageing,' says Dr Pratsides. 'It is not strictly a menopause, which specifically refers to the cessation of menstruation in women where ovulation ends and hormone production plummets during a relatively short period of time instead, it happens over many years.'

Unlike the hormonal drop that occurs in women during this time, sex hormones tend to decrease more gradually in men.

Male menopause is not recognised as a medical condition. The term is often used alongside testosterone deficiency syndrome (TDS), which occurs when the testes produce few or no hormones. TDS is characterised by abnormally low testosterone levels (below 300 ng/dL) and has many different causes.

While it's true that many older men experience TDS approximately 40 per cent of men over the age of 45, according to a study published in the journal Frontiers in Endocrinology, and 50 per cent over the age of 80 abnormally low testosterone levels are not an inevitable result of ageing.

'Some men still maintain a normal level of testosterone throughout their lives, experience no symptoms and can father children well into their eighties,' says Dr Pratsides. TDS can affect men of any age, but when it occurs later in life, it's known as late-onset hypogonadism or androgen decline in the ageing male (ADAM).

The symptoms associated with male menopause are attributed to a gradual age-related decease in testosterone levels. 'Testosterone peaks at around the age of 20 in men,' says Stringer. 'Depending on health, diet and lifestyle factors, testosterone levels should remain consistent during men's twenties. They decline steadily from 30 at around one per cent a year.'

While declining T-levels are a given, 'the extent of decline and the age at which this happens varies even more so with today's lifestyle factors,' she says. The effects appear to be accelerating. One US study identified a 'substantial' drop in the general population since the 1980s, with testosterone levels declining by one per cent per year on average.

Stress, smoking, poor sleep, high body mass index, certain medications, lack of exercise and alcohol are all known to sap testosterone levels. Low T has also been linked to conditions like type 2 diabetes, high cholesterol, high blood pressure, metabolic syndrome and obesity, though it's unclear whether it's a cause or effect.

So, why is male menopause controversial? Some experts suggest that a gradual age-related drop in testosterone is not the primary cause of male menopause symptoms. They believe lifestyle and psychological factors play a far more prominent role. For example, feeling stressed because of problems at work could affect your libido and energy levels.

Male menopause is associated with physical, sexual, and psychological symptoms, that tend to emerge slowly and worsen as you grow older. 'Some men notice symptoms from their thirties, others in their sixties, and some particularly the older generation who were brought up at a time where male hormonal health was not discussed may not acknowledge any change at all,' says Stringer.

Common male menopause symptoms include:

If you're experiencing any of the symptoms associated with male menopause or have any concerns, make an appointment with your doctor.

When you visit your GP they will carry out a detailed check-up based on each of your specific symptoms and address them accordingly. They will also make sure to exclude other medical issues with relevant scans or tests as required.

Your doctor will carry out a detailed check-up based on each of your specific symptoms and address them accordingly.

Your doctor might ask about your personal life to determine whether other factors, such as stress or anxiety, play a part. They may also take a sample of your blood to test your testosterone levels. This will likely take place early or mid-morning, since your testosterone levels fluctuate though the day. A level of less than seven indicates low testosterone. Between seven and 14 is borderline, so further tests may be needed.

Some male menopause symptoms can be treated with hormone replacement therapy if your testosterone levels are found to be low. 'Testosterone replacement can be given in gels, patches, or injections,' says Dr Pratsides. 'It should always be guided by a suitably qualified clinician and obtained from a regulated provider.'

Testosterone treatment has various risks and side effects, including acne, worsened prostate cancer, enlarged breasts, disturbed breathing while sleeping (sleep apnea) and high red blood cell counts, which increases your risk of forming a blood clot. Men using testosterone therapy long-term appear to have a higher risk of heart disease.

If your symptoms are attributed to a combination of physical, lifestyle, and psychological factors, your doctor may adopt a more holistic approach. 'Symptoms of low testosterone due to advancing age can be treated individually,' says Dr Pratsides, 'for example, Viagra to help treat erectile dysfunction, or counselling to treat low mood.'

The simplest way to manage symptoms of male menopause is by making healthier lifestyle choices. Eating a well-balanced diet, making time for regular exercise, getting enough enough sleep, reducing your stress levels, and minimising alcohol and tobacco use are all recommended.

Hormone therapy isn't the only way to give your testosterone reserves a boost. Here are four evidence-based ways to increase your testosterone levels naturally:

Optimise your diet with a balance of carbs, healthy fats and protein. And don't forget the micronutrients. 'Nutrient deficiencies are increasingly common and can cause significant issues for maintaining positive testosterone levels,' says Stringer. B vitamins and zinc are particularly potent, improving sperm quality by 74 per cent in one study. 'Increasing your magnesium intake can raise testosterone levels within a month,' she adds.

Keep your favourite tipple for special occasions. 'Alcohol directly inhibits the production of testosterone in your testes,' says Stringer. 'It can also impact sleep as testosterone levels replenish overnight, this in turn can further impact levels.' Getting five hours a night can slash your T-levels by as much as 15 per cent, the University of Chicago Medical Centre found.

Maintain a healthy weight and pay attention to body fat levels, says Stringer. 'Obesity has a direct and negative impact on testosterone levels,' she explains. 'Fat cells metabolise testosterone to oestrogen, lowering testosterone levels. Also, obesity reduces levels of sex hormone binding globulin (SHBG), a protein that carries testosterone in the blood. Less SHBG means less testosterone.'

If you don't have a workout routine, now's the time to start. 'A 2004 study of older men found that regular physical activity increased testosterone and growth hormone (GH) levels as well as have a positive effect on brain function,' says Stringer. 'Resistance training has shown to be particularly beneficial for testosterone levels.'

Last updated: 28-01-2020

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Male menopause: symptoms, diagnosis and treatment - Netdoctor

Freeman: ‘Pressure to Succeed’ Led to Testosterone Order – Medscape

MANCHESTERThe "pressure" to succeed and willingness to take risks and put what some riders wantedbefore anti-doping rules caused ex-British Cycling and Team Sky head doctor Richard Freeman to order banned testosterone, a medical tribunal heard.

Dr Freeman is accused of ordering 30 sachets of Testogel to the national velodrome in May 2011 in order to dope a rider.

He admits placing the order but claims he was "bullied" into it by head cycling coach Shane Sutton to help treat his erectile dysfunction.

Mr Sutton has denied this and claims Dr Freeman is lying.

In closing submissions before a Medical Practitioners Tribunal Service (MPTS) fitness to practice hearing in Manchester, Simon Jackson QC, for the GMC, discussed a report by endocrinologist Dr Richard Quinton.

Dr Quinton had previously told the tribunal there was no evidence the Testogel was clinically indicated for Shane Sutton.

Mr Jackson said that Dr Freeman "must have known" that was the case and had later "abandoned" that suggestion and instead claimed he'd been bullied.

He said there was no evidence the Testogel was a "step-wise" increase in treatment because there were no records of Viagra (Sildenafil) or Cialis (Tadalafil) being prescribed to Mr Sutton before 2011.

But Cialis was prescribed in 2014 and 2015 which indicated, in Dr Quinton's opinion, that it was working.

Mr Jackson said Dr Quinton had accepted Testogel did have evidence-based off-label uses but he did not accept a single one-off prescription of 30 sachets was indicated in this case.

It had also been prescribed without Dr Freeman undertaking any examination, he said.

Dr Quinton had told the hearing, Mr Jackson said, the Testogel would have "no effect" unless a patient had hypogonadism and Mr Sutton didn't have that condition.

"In his words," Mr Jackson continued, "only 'dodgy doctors still prescribe testosterone in these inappropriate circumstances, namely for a placebo effect.'"

He pointed out that Dr Freeman had admitted in evidence that he'd hadn't prescribed the Testogel as a placebo.

Dr Freeman told UKAD (UK Anti-Doping) investigators in an interview in February 2017 that the Testogel was intended for a non-athlete.

But Mr Jackson questioned why a letter drafted by the doctor's solicitor to UKAD, which asked Mr Sutton to waive his patient confidentiality so those claims could be backed up, had not mentioned any condition or the Testogel.

Mr Jackson told the tribunal that Dr Freeman had repeatedly told lies and they were "part of an established pattern of dishonesty as part of a cover-up".

The lies provided "misleading and ultimately dishonest answers" for why the Testogel had been ordered, he said, and Dr Freeman had been prepared "to keep going and involve other people in this web of deceit".

In summary, Mr Jackson said the GMC's case was that Dr Freeman had placed the order when it wasn't clinically indicated and the intended use was to boost a rider's performance.

He also claimed there was no evidence Mr Sutton had bullied him into it.

"Not only was there no bullying related to the ordering," he said, "there is no basis for concluding that Mr Sutton wanted it, needed it or would have benefited from it in order for him to bully to obtain it.

"But rather we look at all the other circumstances of the pressure on Dr Freeman to succeed, the demonstration that he was a risk-taker and continued to take risks."

Mr Jackson added that Dr Freeman, by his own admission, looked at "what the riders wanted and he didn't focus on what the code prevented".

Dr Freeman has admitted 18 of 22 charges against him, which include lying after attempting to cover-up the order and lying to UKAD.

He's also admitted charges relating to prescribing medicine to non-athlete members of staff and failing to maintain adequate records.

The four charges he denies all relate to the central charge of "knowing or believing" the order was intended to improve an unknown rider's performance.

Mary O'Rourke, Dr Freeman's QC, will begin her final submissions today (Tuesday).

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Freeman: 'Pressure to Succeed' Led to Testosterone Order - Medscape

Hormone Replacement Therapy Market Growth Analysis,Size,Insight,Share And Outlook By 2027 Pfizer, AbbVie, Novo Nordisk NeighborWebSJ – NeighborWebSJ

Hormone replacement therapy 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 competition is intense. Eli Lilly, Pfizer, AbbVie, Novo Nordisk, etc. are the leaders of the industry, and they hold key technologies and patents, with high-end customers. Top 5 players combined 45.13% market share in all.

Market Analysis and Insights:

Global Hormone Replacement Therapy Market The global Hormone Replacement Therapy market size is projected to reach US$ 17720 million by 2026, from US$ 16210 million in 2019, at a CAGR of 1.5% during 2021-2026.

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https://www.qyresearch.com/sample-form/form/2626362/global-hormone-replacement-therapy-market

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Global Hormone Replacement Therapy Scope and Segment Hormone Replacement Therapy market is segmented by Type, and by Application. Players, stakeholders, and other participants in the global Hormone Replacement Therapy market will be able to gain the upper hand as they use the report as a powerful resource. The segmental analysis focuses on production capacity, revenue and forecast by Type and by Application for the period 2016-2027. The following manufacturers are covered in this report:, Eli Lilly, Pfizer, AbbVie, Novo Nordisk, Merck KGaA, Mylan, Bayer, Teva, Novartis, Abbott, Roche, Endo International, Ipsen, ANI Pharmaceuticals, TherapeuticsMD

Hormone Replacement Therapy Breakdown Data by Type

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.

Hormone Replacement Therapy Breakdown Data by Application

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%. Regional and Country-level Analysis The Hormone Replacement Therapy market is analysed and market size information is provided by regions (countries). The key regions covered in the Hormone Replacement Therapy market report are North America, Europe, China, Japan and Middle East. It also covers key regions (countries), viz, the U.S., Canada, Germany, France, U.K., Italy, Russia, China, Japan, South Korea, India, Australia, Taiwan, Indonesia, Thailand, Malaysia, Philippines, Vietnam, Mexico, Brazil, Turkey, Saudi Arabia, U.A.E, etc. The report includes country-wise and region-wise market size for the period 2016-2027. It also includes market size and forecast by Type, and by Application segment in terms of production capacity, price and revenue for the period 2016-2027. Competitive Landscape and Hormone Replacement Therapy Market Share Analysis

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Table of Contents

1 Study Coverage 1.1 Hormone Replacement Therapy Product Introduction 1.2 Market by Type1.2.1 Global Hormone Replacement Therapy Market Size Growth Rate by Type1.4.2 Estrogen Hormone1.4.3 Growth Hormone1.2.4 Thyroid Hormone1.2.5 Testosterone Hormone 1.3 Market by Application1.3.1 Global Hormone Replacement Therapy Market Size Growth Rate by Application1.3.2 Menopause1.3.3 Hypothyroidism1.3.4 Growth Hormone Deficiency1.3.5 Male Hypogonadism1.3.6 Other Diseases 1.4 Study Objectives 1.5 Years Considered 2 Executive Summary 2.1 Global Hormone Replacement Therapy Sales Estimates and Forecasts 2016-2027 2.2 Global Hormone Replacement Therapy Revenue Estimates and Forecasts 2016-2027 2.3 Global Hormone Replacement Therapy Revenue by Region: 2016 VS 2021 VS 2027 2.4 Global Top Hormone Replacement Therapy Regions by Sales2.4.1 Global Top Hormone Replacement Therapy Regions by Sales (2016-2021)2.4.2 Global Top Hormone Replacement Therapy Regions by Sales (2022-2027) 2.5 Global Top Hormone Replacement Therapy Regions by Revenue2.5.1 Global Top Hormone Replacement Therapy Regions by Revenue (2016-2021)2.5.2 Global Top Hormone Replacement Therapy Regions by Revenue (2022-2027) 2.6 North America 2.7 Europe 2.8 Asia-Pacific 2.9 Latin America 2.10 Middle East & Africa 3 Competition by Manufacturers 3.1 Global Hormone Replacement Therapy Sales by Manufacturers3.1.1 Global Top Hormone Replacement Therapy Manufacturers by Sales (2016-2021)3.1.2 Global Top Hormone Replacement Therapy Manufacturers Market Share by Sales (2016-2021)3.1.3 Global Top 10 and Top 5 Companies by Hormone Replacement Therapy Sales in 2020 3.2 Global Hormone Replacement Therapy Revenue by Manufacturers3.2.1 Global Top Hormone Replacement Therapy Manufacturers by Revenue (2016-2021)3.2.2 Global Top Hormone Replacement Therapy Manufacturers Market Share by Revenue (2016-2021)3.2.3 Global Top 10 and Top 5 Companies by Hormone Replacement Therapy Revenue in 2020 3.3 Global Hormone Replacement Therapy Sales Price by Manufacturers 3.4 Analysis of Competitive Landscape3.4.1 Manufacturers Market Concentration Ratio (CR5 and HHI)3.4.2 Global Hormone Replacement Therapy Market Share by Company Type (Tier 1, Tier 2, and Tier 3)3.4.3 Global Hormone Replacement Therapy Manufacturers Geographical Distribution 3.5 Mergers & Acquisitions, Expansion Plans 4 Market Size by Type 4.1 Global Hormone Replacement Therapy Sales by Type4.1.1 Global Hormone Replacement Therapy Historical Sales by Type (2016-2021)4.1.2 Global Hormone Replacement Therapy Forecasted Sales by Type (2022-2027)4.1.3 Global Hormone Replacement Therapy Sales Market Share by Type (2016-2027) 4.2 Global Hormone Replacement Therapy Revenue by Type4.2.1 Global Hormone Replacement Therapy Historical Revenue by Type (2016-2021)4.2.2 Global Hormone Replacement Therapy Forecasted Revenue by Type (2022-2027)4.2.3 Global Hormone Replacement Therapy Revenue Market Share by Type (2016-2027) 4.3 Global Hormone Replacement Therapy Price by Type4.3.1 Global Hormone Replacement Therapy Price by Type (2016-2021)4.3.2 Global Hormone Replacement Therapy Price Forecast by Type (2022-2027) 5 Market Size by Application 5.1 Global Hormone Replacement Therapy Sales by Application5.1.1 Global Hormone Replacement Therapy Historical Sales by Application (2016-2021)5.1.2 Global Hormone Replacement Therapy Forecasted Sales by Application (2022-2027)5.1.3 Global Hormone Replacement Therapy Sales Market Share by Application (2016-2027) 5.2 Global Hormone Replacement Therapy Revenue by Application5.2.1 Global Hormone Replacement Therapy Historical Revenue by Application (2016-2021)5.2.2 Global Hormone Replacement Therapy Forecasted Revenue by Application (2022-2027)5.2.3 Global Hormone Replacement Therapy Revenue Market Share by Application (2016-2027) 5.3 Global Hormone Replacement Therapy Price by Application5.3.1 Global Hormone Replacement Therapy Price by Application (2016-2021)5.3.2 Global Hormone Replacement Therapy Price Forecast by Application (2022-2027) 6 North America 6.1 North America Hormone Replacement Therapy Market Size by Type6.1.1 North America Hormone Replacement Therapy Sales by Type (2016-2027)6.1.2 North America Hormone Replacement Therapy Revenue by Type (2016-2027) 6.2 North America Hormone Replacement Therapy Market Size by Application6.2.1 North America Hormone Replacement Therapy Sales by Application (2016-2027)6.2.2 North America Hormone Replacement Therapy Revenue by Application (2016-2027) 6.3 North America Hormone Replacement Therapy Market Size by Country6.3.1 North America Hormone Replacement Therapy Sales by Country (2016-2027)6.3.2 North America Hormone Replacement Therapy Revenue by Country (2016-2027)6.3.3 U.S.6.3.4 Canada 7 Europe 7.1 Europe Hormone Replacement Therapy Market Size by Type7.1.1 Europe Hormone Replacement Therapy Sales by Type (2017-2027)7.1.2 Europe Hormone Replacement Therapy Revenue by Type (2017-2027) 7.2 Europe Hormone Replacement Therapy Market Size by Application7.2.1 Europe Hormone Replacement Therapy Sales by Application (2017-2027)7.2.2 Europe Hormone Replacement Therapy Revenue by Application (2017-2027) 7.3 Europe Hormone Replacement Therapy Market Size by Country7.3.1 Europe Hormone Replacement Therapy Sales by Country (2017-2027)7.3.2 Europe Hormone Replacement Therapy Revenue by Country (2017-2027)7.3.3 Germany7.3.4 France7.3.5 U.K.7.3.6 Italy7.3.7 Russia 8 Asia Pacific 8.1 Asia Pacific Hormone Replacement Therapy Market Size by Type8.1.1 Asia Pacific Hormone Replacement Therapy Sales by Type (2018-2027)8.1.2 Asia Pacific Hormone Replacement Therapy Revenue by Type (2018-2027) 8.2 Asia Pacific Hormone Replacement Therapy Market Size by Application8.2.1 Asia Pacific Hormone Replacement Therapy Sales by Application (2018-2027)8.2.2 Asia Pacific Hormone Replacement Therapy Revenue by Application (2018-2027) 8.3 Asia Pacific Hormone Replacement Therapy Market Size by Region8.3.1 Asia Pacific Hormone Replacement Therapy Sales by Region (2018-2027)8.3.2 Asia Pacific Hormone Replacement Therapy Revenue by Region (2018-2027)8.3.3 China8.3.4 Japan8.3.5 South Korea8.3.6 India8.3.7 Australia8.3.8 Taiwan8.3.9 Indonesia8.3.10 Thailand8.3.11 Malaysia8.3.12 Philippines 9 Latin America 9.1 Latin America Hormone Replacement Therapy Market Size by Type9.1.1 Latin America Hormone Replacement Therapy Sales by Type (2019-2027)9.1.2 Latin America Hormone Replacement Therapy Revenue by Type (2019-2027) 9.2 Latin America Hormone Replacement Therapy Market Size by Application9.2.1 Latin America Hormone Replacement Therapy Sales by Application (2019-2027)9.2.2 Latin America Hormone Replacement Therapy Revenue by Application (2019-2027) 9.3 Latin America Hormone Replacement Therapy Market Size by Country9.3.1 Latin America Hormone Replacement Therapy Sales by Country (2019-2027)9.3.2 Latin America Hormone Replacement Therapy Revenue by Country (2019-2027)9.3.3 Mexico9.3.4 Brazil9.3.5 Argentina 6 Middle East and Africa 6.1 Middle East and Africa Hormone Replacement Therapy Market Size by Type6.1.1 Middle East and Africa Hormone Replacement Therapy Sales by Type (2016-2027)6.1.2 Middle East and Africa Hormone Replacement Therapy Revenue by Type (2016-2027) 6.2 Middle East and Africa Hormone Replacement Therapy Market Size by Application6.2.1 Middle East and Africa Hormone Replacement Therapy Sales by Application (2016-2027)6.2.2 Middle East and Africa Hormone Replacement Therapy Revenue by Application (2016-2027) 6.3 Middle East and Africa Hormone Replacement Therapy Market Size by Country6.3.1 Middle East and Africa Hormone Replacement Therapy Sales by Country (2016-2027)6.3.2 Middle East and Africa Hormone Replacement Therapy Revenue by Country (2016-2027)6.3.3 Turkey6.3.4 Saudi Arabia6.3.5 U.A.E 11 Company Profiles 11.1 Eli Lilly11.1.1 Eli Lilly Corporation Information11.1.2 Eli Lilly Overview11.1.3 Eli Lilly Hormone Replacement Therapy Sales, Price, Revenue and Gross Margin (2016-2021)11.1.4 Eli Lilly Hormone Replacement Therapy Product Description11.1.5 Eli Lilly Related Developments 11.2 Pfizer11.2.1 Pfizer Corporation Information11.2.2 Pfizer Overview11.2.3 Pfizer Hormone Replacement Therapy Sales, Price, Revenue and Gross Margin (2016-2021)11.2.4 Pfizer Hormone Replacement Therapy Product Description11.2.5 Pfizer Related Developments 11.3 AbbVie11.3.1 AbbVie Corporation Information11.3.2 AbbVie Overview11.3.3 AbbVie Hormone Replacement Therapy Sales, Price, Revenue and Gross Margin (2016-2021)11.3.4 AbbVie Hormone Replacement Therapy Product Description11.3.5 AbbVie Related Developments 11.4 Novo Nordisk11.4.1 Novo Nordisk Corporation Information11.4.2 Novo Nordisk Overview11.4.3 Novo Nordisk Hormone Replacement Therapy Sales, Price, Revenue and Gross Margin (2016-2021)11.4.4 Novo Nordisk Hormone Replacement Therapy Product Description11.4.5 Novo Nordisk Related Developments 11.5 Merck KGaA11.5.1 Merck KGaA Corporation Information11.5.2 Merck KGaA Overview11.5.3 Merck KGaA Hormone Replacement Therapy Sales, Price, Revenue and Gross Margin (2016-2021)11.5.4 Merck KGaA Hormone Replacement Therapy Product Description11.5.5 Merck KGaA Related Developments 11.6 Mylan11.6.1 Mylan Corporation Information11.6.2 Mylan Overview11.6.3 Mylan Hormone Replacement Therapy Sales, Price, Revenue and Gross Margin (2016-2021)11.6.4 Mylan Hormone Replacement Therapy Product Description11.6.5 Mylan Related Developments 11.7 Bayer11.7.1 Bayer Corporation Information11.7.2 Bayer Overview11.7.3 Bayer Hormone Replacement Therapy Sales, Price, Revenue and Gross Margin (2016-2021)11.7.4 Bayer Hormone Replacement Therapy Product Description11.7.5 Bayer Related Developments 11.8 Teva11.8.1 Teva Corporation Information11.8.2 Teva Overview11.8.3 Teva Hormone Replacement Therapy Sales, Price, Revenue and Gross Margin (2016-2021)11.8.4 Teva Hormone Replacement Therapy Product Description11.8.5 Teva Related Developments 11.9 Novartis11.9.1 Novartis Corporation Information11.9.2 Novartis Overview11.9.3 Novartis Hormone Replacement Therapy Sales, Price, Revenue and Gross Margin (2016-2021)11.9.4 Novartis Hormone Replacement Therapy Product Description11.9.5 Novartis Related Developments 11.10 Abbott11.10.1 Abbott Corporation Information11.10.2 Abbott Overview11.10.3 Abbott Hormone Replacement Therapy Sales, Price, Revenue and Gross Margin (2016-2021)11.10.4 Abbott Hormone Replacement Therapy Product Description11.10.5 Abbott Related Developments 11.1 Eli Lilly11.1.1 Eli Lilly Corporation Information11.1.2 Eli Lilly Overview11.1.3 Eli Lilly Hormone Replacement Therapy Sales, Price, Revenue and Gross Margin (2016-2021)11.1.4 Eli Lilly Hormone Replacement Therapy Product Description11.1.5 Eli Lilly Related Developments 11.12 Endo International11.12.1 Endo International Corporation Information11.12.2 Endo International Overview11.12.3 Endo International Hormone Replacement Therapy Sales, Price, Revenue and Gross Margin (2016-2021)11.12.4 Endo International Product Description11.12.5 Endo International Related Developments 11.13 Ipsen11.13.1 Ipsen Corporation Information11.13.2 Ipsen Overview11.13.3 Ipsen Hormone Replacement Therapy Sales, Price, Revenue and Gross Margin (2016-2021)11.13.4 Ipsen Product Description11.13.5 Ipsen Related Developments 11.14 ANI Pharmaceuticals11.14.1 ANI Pharmaceuticals Corporation Information11.14.2 ANI Pharmaceuticals Overview11.14.3 ANI Pharmaceuticals Hormone Replacement Therapy Sales, Price, Revenue and Gross Margin (2016-2021)11.14.4 ANI Pharmaceuticals Product Description11.14.5 ANI Pharmaceuticals Related Developments 11.15 TherapeuticsMD11.15.1 TherapeuticsMD Corporation Information11.15.2 TherapeuticsMD Overview11.15.3 TherapeuticsMD Hormone Replacement Therapy Sales, Price, Revenue and Gross Margin (2016-2021)11.15.4 TherapeuticsMD Product Description11.15.5 TherapeuticsMD Related Developments 12 Value Chain and Sales Channels Analysis 12.1 Hormone Replacement Therapy Value Chain Analysis 12.2 Hormone Replacement Therapy Key Raw Materials12.2.1 Key Raw Materials12.2.2 Raw Materials Key Suppliers 12.3 Hormone Replacement Therapy Production Mode & Process 12.4 Hormone Replacement Therapy Sales and Marketing12.4.1 Hormone Replacement Therapy Sales Channels12.4.2 Hormone Replacement Therapy Distributors 12.5 Hormone Replacement Therapy Customers 13 Market Drivers, Opportunities, Challenges and Risks Factors Analysis 13.1 Hormone Replacement Therapy Industry Trends 13.2 Hormone Replacement Therapy Market Drivers 13.3 Hormone Replacement Therapy Market Challenges 13.4 Hormone Replacement Therapy Market Restraints 14 Key Findings in The Global Hormone Replacement Therapy Study 15 Appendix 15.1 Research Methodology15.1.1 Methodology/Research Approach15.1.2 Data Source 15.2 Author Details 15.3 Disclaimer

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Hormone Replacement Therapy Market Growth Analysis,Size,Insight,Share And Outlook By 2027 Pfizer, AbbVie, Novo Nordisk NeighborWebSJ - NeighborWebSJ

Male Hypogonadism Therapy Market to Witness Massive Growth During 2021-2027 | 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 2021-2027. 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

1 Report Overview1.1 Study Scope1.2 Market Analysis by Type1.2.1 Global Male Hypogonadism Therapy Market Size Growth Rate by Type: 2016 VS 2021 VS 20271.2.2 Parenteral1.2.3 Transdermal1.2.4 Oral1.2.5 Others1.3 Market by Application1.3.1 Global Male Hypogonadism Therapy Market Share by Application: 2016 VS 2021 VS 20271.3.2 Hospitals1.3.3 Drugstores1.3.4 Others1.4 Study Objectives1.5 Years Considered 2 Global Growth Trends2.1 Global Male Hypogonadism Therapy Market Perspective (2016-2027)2.2 Male Hypogonadism Therapy Growth Trends by Regions2.2.1 Male Hypogonadism Therapy Market Size by Regions: 2016 VS 2021 VS 20272.2.2 Male Hypogonadism Therapy Historic Market Share by Regions (2016-2021)2.2.3 Male Hypogonadism Therapy Forecasted Market Size by Regions (2022-2027)2.3 Male Hypogonadism Therapy Industry Dynamic2.3.1 Male Hypogonadism Therapy Market Trends2.3.2 Male Hypogonadism Therapy Market Drivers2.3.3 Male Hypogonadism Therapy Market Challenges2.3.4 Male Hypogonadism Therapy Market Restraints 3 Competition Landscape by Key Players3.1 Global Top Male Hypogonadism Therapy Players by Revenue3.1.1 Global Top Male Hypogonadism Therapy Players by Revenue (2016-2021)3.1.2 Global Male Hypogonadism Therapy Revenue Market Share by Players (2016-2021)3.2 Global Male Hypogonadism Therapy Market Share by Company Type (Tier 1, Tier 2 and Tier 3)3.3 Players Covered: Ranking by Male Hypogonadism Therapy Revenue3.4 Global Male Hypogonadism Therapy Market Concentration Ratio3.4.1 Global Male Hypogonadism Therapy Market Concentration Ratio (CR5 and HHI)3.4.2 Global Top 10 and Top 5 Companies by Male Hypogonadism Therapy Revenue in 20203.5 Male Hypogonadism Therapy Key Players Head office and Area Served3.6 Key Players Male Hypogonadism Therapy Product Solution and Service3.7 Date of Enter into Male Hypogonadism Therapy Market3.8 Mergers & Acquisitions, Expansion Plans 4 Male Hypogonadism Therapy Breakdown Data by Type4.1 Global Male Hypogonadism Therapy Historic Market Size by Type (2016-2021)4.2 Global Male Hypogonadism Therapy Forecasted Market Size by Type (2022-2027) 5 Male Hypogonadism Therapy Breakdown Data by Application5.1 Global Male Hypogonadism Therapy Historic Market Size by Application (2016-2021)5.2 Global Male Hypogonadism Therapy Forecasted Market Size by Application (2022-2027) 6 North America6.1 North America Male Hypogonadism Therapy Market Size (2016-2027)6.2 North America Male Hypogonadism Therapy Market Size by Type6.2.1 North America Male Hypogonadism Therapy Market Size by Type (2016-2021)6.2.2 North America Male Hypogonadism Therapy Market Size by Type (2022-2027)6.2.3 North America Male Hypogonadism Therapy Market Size by Type (2016-2027)6.3 North America Male Hypogonadism Therapy Market Size by Application6.3.1 North America Male Hypogonadism Therapy Market Size by Application (2016-2021)6.3.2 North America Male Hypogonadism Therapy Market Size by Application (2022-2027)6.3.3 North America Male Hypogonadism Therapy Market Size by Application (2016-2027)6.4 North America Male Hypogonadism Therapy Market Size by Country6.4.1 North America Male Hypogonadism Therapy Market Size by Country (2016-2021)6.4.2 North America Male Hypogonadism Therapy Market Size by Country (2022-2027)6.4.3 United States6.4.3 Canada 7 Europe7.1 Europe Male Hypogonadism Therapy Market Size (2016-2027)7.2 Europe Male Hypogonadism Therapy Market Size by Type7.2.1 Europe Male Hypogonadism Therapy Market Size by Type (2016-2021)7.2.2 Europe Male Hypogonadism Therapy Market Size by Type (2022-2027)7.2.3 Europe Male Hypogonadism Therapy Market Size by Type (2016-2027)7.3 Europe Male Hypogonadism Therapy Market Size by Application7.3.1 Europe Male Hypogonadism Therapy Market Size by Application (2016-2021)7.3.2 Europe Male Hypogonadism Therapy Market Size by Application (2022-2027)7.3.3 Europe Male Hypogonadism Therapy Market Size by Application (2016-2027)7.4 Europe Male Hypogonadism Therapy Market Size by Country7.4.1 Europe Male Hypogonadism Therapy Market Size by Country (2016-2021)7.4.2 Europe Male Hypogonadism Therapy Market Size by Country (2022-2027)7.4.3 Germany7.4.4 France7.4.5 U.K.7.4.6 Italy7.4.7 Russia7.4.8 Nordic 8 Asia-Pacific8.1 Asia-Pacific Male Hypogonadism Therapy Market Size (2016-2027)8.2 Asia-Pacific Male Hypogonadism Therapy Market Size by Type8.2.1 Asia-Pacific Male Hypogonadism Therapy Market Size by Type (2016-2021)8.2.2 Asia-Pacific Male Hypogonadism Therapy Market Size by Type (2022-2027)8.2.3 Asia-Pacific Male Hypogonadism Therapy Market Size by Type (2016-2027)8.3 Asia-Pacific Male Hypogonadism Therapy Market Size by Application8.3.1 Asia-Pacific Male Hypogonadism Therapy Market Size by Application (2016-2021)8.3.2 Asia-Pacific Male Hypogonadism Therapy Market Size by Application (2022-2027)8.3.3 Asia-Pacific Male Hypogonadism Therapy Market Size by Application (2016-2027)8.4 Asia-Pacific Male Hypogonadism Therapy Market Size by Region8.4.1 Asia-Pacific Male Hypogonadism Therapy Market Size by Region (2016-2021)8.4.2 Asia-Pacific Male Hypogonadism Therapy Market Size by Region (2022-2027)8.4.3 China8.4.4 Japan8.4.5 South Korea8.4.6 Southeast Asia8.4.7 India8.4.8 Australia 9 Latin America9.1 Latin America Male Hypogonadism Therapy Market Size (2016-2027)9.2 Latin America Male Hypogonadism Therapy Market Size by Type9.2.1 Latin America Male Hypogonadism Therapy Market Size by Type (2016-2021)9.2.2 Latin America Male Hypogonadism Therapy Market Size by Type (2022-2027)9.2.3 Latin America Male Hypogonadism Therapy Market Size by Type (2016-2027)9.3 Latin America Male Hypogonadism Therapy Market Size by Application9.3.1 Latin America Male Hypogonadism Therapy Market Size by Application (2016-2021)9.3.2 Latin America Male Hypogonadism Therapy Market Size by Application (2022-2027)9.3.3 Latin America Male Hypogonadism Therapy Market Size by Application (2016-2027)9.4 Latin America Male Hypogonadism Therapy Market Size by Country9.4.1 Latin America Male Hypogonadism Therapy Market Size by Country (2016-2021)9.4.2 Latin America Male Hypogonadism Therapy Market Size by Country (2022-2027)9.4.3 Mexico9.4.4 Brazil 10 Middle East & Africa10.1 Middle East & Africa Male Hypogonadism Therapy Market Size (2016-2027)10.2 Middle East & Africa Male Hypogonadism Therapy Market Size by Type10.2.1 Middle East & Africa Male Hypogonadism Therapy Market Size by Type (2016-2021)10.2.2 Middle East & Africa Male Hypogonadism Therapy Market Size by Type (2022-2027)10.2.3 Middle East & Africa Male Hypogonadism Therapy Market Size by Type (2016-2027)10.3 Middle East & Africa Male Hypogonadism Therapy Market Size by Application10.3.1 Middle East & Africa Male Hypogonadism Therapy Market Size by Application (2016-2021)10.3.2 Middle East & Africa Male Hypogonadism Therapy Market Size by Application (2022-2027)10.3.3 Middle East & Africa Male Hypogonadism Therapy Market Size by Application (2016-2027)10.4 Middle East & Africa Male Hypogonadism Therapy Market Size by Country10.4.1 Middle East & Africa Male Hypogonadism Therapy Market Size by Country (2016-2021)10.4.2 Middle East & Africa Male Hypogonadism Therapy Market Size by Country (2022-2027)10.4.3 Turkey10.4.4 Saudi Arabia10.4.5 UAE 11 Key Players Profiles11.1 Eli Lilly11.1.1 Eli Lilly Company Details11.1.2 Eli Lilly Business Overview11.1.3 Eli Lilly Male Hypogonadism Therapy Introduction11.1.4 Eli Lilly Revenue in Male Hypogonadism Therapy Business (2016-2021)11.1.5 Eli Lilly Recent Development11.2 Pfizer11.2.1 Pfizer Company Details11.2.2 Pfizer Business Overview11.2.3 Pfizer Male Hypogonadism Therapy Introduction11.2.4 Pfizer Revenue in Male Hypogonadism Therapy Business (2016-2021)11.2.5 Pfizer Recent Development11.3 AbbVie11.3.1 AbbVie Company Details11.3.2 AbbVie Business Overview11.3.3 AbbVie Male Hypogonadism Therapy Introduction11.3.4 AbbVie Revenue in Male Hypogonadism Therapy Business (2016-2021)11.3.5 AbbVie Recent Development11.4 Novo Nordisk11.4.1 Novo Nordisk Company Details11.4.2 Novo Nordisk Business Overview11.4.3 Novo Nordisk Male Hypogonadism Therapy Introduction11.4.4 Novo Nordisk Revenue in Male Hypogonadism Therapy Business (2016-2021)11.4.5 Novo Nordisk Recent Development11.5 Merck KGaA11.5.1 Merck KGaA Company Details11.5.2 Merck KGaA Business Overview11.5.3 Merck KGaA Male Hypogonadism Therapy Introduction11.5.4 Merck KGaA Revenue in Male Hypogonadism Therapy Business (2016-2021)11.5.5 Merck KGaA Recent Development11.6 Mylan11.6.1 Mylan Company Details11.6.2 Mylan Business Overview11.6.3 Mylan Male Hypogonadism Therapy Introduction11.6.4 Mylan Revenue in Male Hypogonadism Therapy Business (2016-2021)11.6.5 Mylan Recent Development11.7 Bayer11.7.1 Bayer Company Details11.7.2 Bayer Business Overview11.7.3 Bayer Male Hypogonadism Therapy Introduction11.7.4 Bayer Revenue in Male Hypogonadism Therapy Business (2016-2021)11.7.5 Bayer Recent Development11.8 Teva11.8.1 Teva Company Details11.8.2 Teva Business Overview11.8.3 Teva Male Hypogonadism Therapy Introduction11.8.4 Teva Revenue in Male Hypogonadism Therapy Business (2016-2021)11.8.5 Teva Recent Development11.9 Novartis11.9.1 Novartis Company Details11.9.2 Novartis Business Overview11.9.3 Novartis Male Hypogonadism Therapy Introduction11.9.4 Novartis Revenue in Male Hypogonadism Therapy Business (2016-2021)11.9.5 Novartis Recent Development11.10 Abbott11.10.1 Abbott Company Details11.10.2 Abbott Business Overview11.10.3 Abbott Male Hypogonadism Therapy Introduction11.10.4 Abbott Revenue in Male Hypogonadism Therapy Business (2016-2021)11.10.5 Abbott Recent Development11.11 Roche11.11.1 Roche Company Details11.11.2 Roche Business Overview11.11.3 Roche Male Hypogonadism Therapy Introduction11.11.4 Roche Revenue in Male Hypogonadism Therapy Business (2016-2021)11.11.5 Roche Recent Development11.12 Endo International11.12.1 Endo International Company Details11.12.2 Endo International Business Overview11.12.3 Endo International Male Hypogonadism Therapy Introduction11.12.4 Endo International Revenue in Male Hypogonadism Therapy Business (2016-2021)11.12.5 Endo International Recent Development11.13 Ipsen11.13.1 Ipsen Company Details11.13.2 Ipsen Business Overview11.13.3 Ipsen Male Hypogonadism Therapy Introduction11.13.4 Ipsen Revenue in Male Hypogonadism Therapy Business (2016-2021)11.13.5 Ipsen Recent Development11.14 ANI Pharmaceuticals11.14.1 ANI Pharmaceuticals Company Details11.14.2 ANI Pharmaceuticals Business Overview11.14.3 ANI Pharmaceuticals Male Hypogonadism Therapy Introduction11.14.4 ANI Pharmaceuticals Revenue in Male Hypogonadism Therapy Business (2016-2021)11.14.5 ANI Pharmaceuticals Recent Development11.15 TherapeuticsMD11.15.1 TherapeuticsMD Company Details11.15.2 TherapeuticsMD Business Overview11.15.3 TherapeuticsMD Male Hypogonadism Therapy Introduction11.15.4 TherapeuticsMD Revenue in Male Hypogonadism Therapy Business (2016-2021)11.15.5 TherapeuticsMD Recent Development 12 Analysts Viewpoints/Conclusions 13 Appendix13.1 Research Methodology13.1.1 Methodology/Research Approach13.1.2 Data Source13.2 Disclaimer13.3 Author Details

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Male Hypogonadism Therapy Market to Witness Massive Growth During 2021-2027 | Eli Lilly, Pfizer, AbbVie, Novo Nordisk, Merck KGaA, Mylan, Bayer, Teva,...

Male Hypogonadism Therapy Market and Ecosystem by Production, Prospects, Consumption, Cost Structure, Competitive Landscape – Jumbo News

The Global Male Hypogonadism Therapy Market report provides a basic overview of the industry including definitions, classifications, applications and industry chain structure. The Male Hypogonadism Therapy market analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status. The report provides key statistics on the market status of the Male Hypogonadism Therapy manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the industry.

Report Highlights

Global Male Hypogonadism Therapy Market is expected to grow at a formidable rate and the market size will reach at remarkable number by 2025.The Global Male Hypogonadism Therapy market report also provides CAGR from 2020 to 2025.Key players in this market are Eli Lilly, Teva, Novo Nordisk, Pfizer, Bayer, AbbVie, Abbott, Mylan, Merck KGaA, Novartis, TherapeuticsMD, Roche, ANI Pharmaceuticals, Endo International, Ipsen, etc.

Complete report on Male Hypogonadism Therapy market spreads across 133 pages profiling companies and supported with tables and figures.

Our industry professionals are working relentlessly to understand, assemble and timely deliver assessment on impact of COVID-19 disaster on many corporations and their clients to help them in taking excellent business decisions. We acknowledge everyone who is doing their part in this financial and healthcare crisis.

Effect of COVID-19: Male Hypogonadism Therapy Market report investigate the effect of Coronavirus (COVID-19) on the Male Hypogonadism Therapy industry. Since December 2020, the COVID-19 infection spread to practically 180+ nations around the world with the World Health Organization pronouncing it a general wellbeing crisis. The worldwide effects of the Covid infection 2020 (COVID-19) are now beginning to be felt, and will essentially influence the Male Hypogonadism Therapy market in 2020

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The major types mentioned in the report are Parenteral, Transdermal, Oral, Others,and the applications covered in the report are Hospitals, Drugstores, Others,.

The report provides insights in the following areas:

Market Size: Accurate market size and CAGR forecasts for the period 2020-2025

Also the mentioned Tables and Figure with required and significant statistics and insights are there in our report to give an all-round idea to our clients.

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Major Points from the Table of Contents

1 Male Hypogonadism Therapy Market Overview

2 Global Male Hypogonadism Therapy Market Competition by Manufacturers

3 Global Male Hypogonadism Therapy Capacity, Production, Revenue (Value) by Region)

4 Global Male Hypogonadism Therapy Supply (Production), Consumption, Export, Import by Region

5 Global Male Hypogonadism Therapy Production, Revenue (Value), Price Trend by Type

6 Global Male Hypogonadism Therapy Market Analysis by Application

7 Global Male Hypogonadism Therapy Manufacturers Profiles/Analysis

8 Male Hypogonadism Therapy Manufacturing Cost Analysis

9 Industrial Chain, Sourcing Strategy and Downstream Buyers

10 Marketing Strategy Analysis, Distributors/Traders

11 Market Effect Factors Analysis

12 Global Male Hypogonadism Therapy Market Forecast

13 Research Findings and Conclusion

14 Appendix

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Male Hypogonadism Therapy Market and Ecosystem by Production, Prospects, Consumption, Cost Structure, Competitive Landscape - Jumbo News

What is Harvey Prices disability Prader-Willi Syndrome? – The Sun

PRADER-WILLI syndrome is a rare genetic condition that affects one in 15,000 children in England.

While the condition itself isn't life-threatening, but its symptoms such as compulsive eating and weight gain can cause complications. Katie Price's eldest child Harvey, 18, was born with PWS and has now been administered into full-time care care so that he is able to be more independent life and learn new skills.

PWS is a genetic condition that can impact muscle tone, sexual development and the function of the nervous system.

As well as this, those with Prader-Willi syndrome are more likely to have learning difficulties.

Often, it also sparks a constant desire to eat food and a permanent feeling of hunger which leads to child obesity.

However, the syndrome is very rare, with the NHS estimating that it affects "no more than one in every 15,000 children born in England".

Those with PWS have a genetic defect on chromosome number 15.

In around 70 per cent of cases, some of the DNA information that's inherited from the father is missing, which is referred to as "paternal deletion".

Other cases occurwhen a child has two copies from their mother and none from their father.

The condition is obtained purely by chance, but those who have one child with PWS have a less than 1 per cent chance of the next one being affected.

Genetic tests are used to diagnose PWS.

Medical professionals will often carry out this check if they identify someone who is displaying the symptoms of Prader-Willi syndrome.

The NHS offers more detailed criteria for diagnosis on their website.

The Prader-Will Syndrome Association UK describes the medical characteristics of the condition as:

Hypotonia: weak muscle tone, and floppiness at birth. Hypogonadism: immature development of sexual organs and other sexual characteristics. Obesity: caused by excessive appetite and overeating (hyperphagia), and a decreased calorific requirement owing to low energy expenditure levels, although obesity is not normally a feature of those whose food intake is strictly controlled. Central nervous system and endocrine gland dysfunction: causing varying degrees of learning disability, short stature, hyperphagia, somnolence (excessive sleepiness), and poor emotional and social development.

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As children with PWS can consume three to six times more food than other kids of the same age, there is a huge risk of obesity.

Consuming food compulsively can also lead to your stomach becoming abnormally expanded.

Young adults who have been diagnosed also run the risk of type 2 diabetes and heart failure if they don't control their eating.

As it currently stands, there is no cure for PWS.

Those who have been diagnosed with the condition are encouraged to take measures to lessen the severity of symptoms and associated problems.

Parents of child sufferers are asked to monitor any excessive eating and try to keep balanced and healthy meals on the menu.

3

Katie is raising awareness on new BBC show Katie Price: Harvey and Me on January 25 at 8.30pm, which documents her life as her sons carer.

Harvey Price is partially blind, autistic and has Prader-Willi syndrome and mum Katie has made the heart-wrenching decision to put Harvey into care.

She told The Sun: It breaks my heart. I dont want him to think Im just getting rid of him.

The move will gives him the best chance to forge an independent life and learn new skills.

In the past, Harvey's condition has led to major health concerns, as his condition makes him constantly feel hungry.

Katie had revealed doctors have warned that the battle to keep Harvey alive is critical as he could drop dead from a heart attack if he doesnt lose weight urgently.

She said: Its a cruel illness. He feels hungry all the time. Every time I feed him, its killing him.

Even though it makes him happy, its cruel of me to do it.

He needs to lose weight or hell end up dead. He doesnt deserve that. I dont want to lose him."

The reality star also says she's a "bloody good mum" and she hates it when people credit her exes for their "polite" kids.

3

When speaking to The Sun in a brutally honest chat ahead of new BBC documentary Katie Price: Harvey and Me, she declared: "I don't need to justify myself as a mother - I know I'm a bloody good mum.

"I can take my kids anywhere and wherever I've taken my kids, everyone is like, 'I can't believe how polite your kids are they're a pleasure to have', and that is down to me, their parenting and their dads as well."

She added: "The kids love coming to me, I'm completely different, I'm the laid back one.

"They get a bit of both, they get the strict parent and the easy going one where they can stay up later and watch a movie."

Harvey's homeWhat care is Katie Price's son Harvey going into?

PRICEY HOBBYBankrupt Katie Price spends 80 on scratch cards - but only wins 20

ABOUT HARVEYHow old is Katie Price's son Harvey Price and why is he going into care?

THE LIFE OF PRICEKatie Price family tree - all her children and marriages

'INSPIRING'Katie Price shows off new hair as This Morning viewers praise her mum skills

The former glamour model also spoke about Harvey's condition while filming her reality series My Crazy Life.

She said: "If he doesn't sort it out he will die, we've been told, because of his heart."

In a 2017 interview on Loose Women, Katie said:"He never knows when he's full up, he'll do anything he can to feed himself."

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What is Harvey Prices disability Prader-Willi Syndrome? - The Sun

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