Page 1123

Archive for the ‘Hypogonadism’ Category

Ads for low-testosterone treatments benefit sales but not necessarily health – Science Daily

Ads for low-testosterone treatments benefit sales but not necessarily health
Science Daily
The likelihood of hypogonadism increases with age and can cause symptoms such as low libido, reduced strength, fatigue and depression. It is diagnosed with a blood test together with clinical symptoms and signs, and it is treated with products that

View post:
Ads for low-testosterone treatments benefit sales but not necessarily health – Science Daily

Sport and male sexuality. – UroToday

The relationships between sport and sexuality in males are of great social and clinical interest, because of sports and motor activities that highly promote social and sexual relationships. Even if few literature exist, two main questions should be taken into account: whether and how physical exercise and sport positively or negatively influence sexual health and behavior and/or whether and how sexual behavior may affect a sub-sequent sport performance. Physical exercise and sport per se can influence, positively or negatively, the hypothalamic-pituitary-testicular axis function and, consequently, the individual’s reproductive and/or sexual health. This depends on individual factors such as genetic and epigenetic ones and on different variables involved in the practice of sport activities (type of sport, intensity and duration of training, doping and drug use and abuse, nutrition, supplements, psychological stress, allostatic load, etc.). If well conducted, motor and sport activities could have beneficial effects on sexual health in males. Among different lifestyle changes, influencing sexual health, regular physical activity is fundamental to antagonize the onset of erectile dysfunction (ED). However, competitive sport can lead both reproductive and/or sexual tract damages and dysfunctions, transient (genital pain, hypoesthesia of the genitalia, hypogonadism, DE, altered sexual drive, etc.) or permanent (hypogonadism, DE, etc.), by acting directly (traumas of the external genitalia, saddle-related disorders in cyclists, etc.) or indirectly (exercise-related hypogonadism, drug abuse, doping, stress, etc.). Sexual activities shortly performed before a sport competition could differently influence sport performance. Due to the few existing data, it is advisable to avoid an absolute pre-competition sexual abstinence.

Journal of endocrinological investigation. 2017 Mar 22 [Epub ahead of print]

P Sgr, L Di Luigi

Unit of Endocrinology, Section of Health Sciences, Department of Movement, Human and Health Sciences, University of Rome “Foro Italico”, Rome, Italy., Unit of Endocrinology, Section of Health Sciences, Department of Movement, Human and Health Sciences, University of Rome “Foro Italico”, Rome, Italy. .

PubMed http://www.ncbi.nlm.nih.gov/pubmed/28332171

See the original post:
Sport and male sexuality. – UroToday

Smaller bone size less bone turnover in men with hypogonadism type 2 diabetes – Healio

Smaller bone size less bone turnover in men with hypogonadism type 2 diabetes
Healio
Men with hypogonadism and type 2 diabetes have a higher bone mineral density, but smaller bone area and lower bone turnover rate compared with men with hypogonadism but without diabetes, according to findings from a cross-sectional study.

View post:
Smaller bone size less bone turnover in men with hypogonadism type 2 diabetes – Healio

JAMA confirms DTC drove ‘Low-T’ craze – BioPharma Dive

Dive Brief:

“Low-T” was not a common term before 2009, but direct-to-consumer advertising by the makers of testosterone medications made it a household condition, despite there being little evidence of an actual problem.

Testosterone gels and creams are typically approved for men with pathological hypogonadism, a low hormone condition that can arise after chemotherapy for prostate cancer. Yet, the pharmaceutical industry spent years advertising the products to treat an unsubstantiated “lifestyle” condition for men who werent feeling quite “manly” or had a low sex drive, despite little to no safety or efficacy data supporting these claims.

“Advertising intensity varied by geographic region and time, with the highest intensity seen in the southeastern United States and with months ranging from no ad exposures to a mean of 13.6 exposures per household,” noted the JAMA report. “Non-branded advertisements were common prior to 2012, with branded advertisements becoming more common during and after 2012. Each household advertisement exposure was associated with a monthly increase in rates of new testosterone testing.”

The “Low-T” craze became an exercise in how pharma companies can abuse the direct-to-consumer advertising paradigm. DTC ads are common across therapeutics areas in the U.S., but generally not allowed in other countries. The practice of advertising drugs directly to patients has long been criticized by those within and outside the industry.

AbbVie precursor Abbott Laboratories acquired AndroGel, a major player in the low-T segment, in 2010 from Solvay Pharmaceuticals. The commercialization engine at AbbVie then began promoting the drug. By 2013, AndroGel became AbbVies best-selling drug behind its blockbuster rheumatoid arthritis treatment Humira, with more than $1 billion in sales. The drug had grown by more than 55% during the course of 2012 alone, largely driven by the off-label use in “Low-T” patients.

AndroGel was the dominant player in this space until the Food and Drug Administration began cracking down on the treatments. In 2016, the FDA issued its third warning in three years about the testosterone category, reporting that abuse of the treatments could cause heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility.

The first of the product liability suits for AndroGel are expected to begin in June of this year, alleging that the company did not adequately warn of the risks of the drug and promoted it off-label for the use of “Low-T.”

More here:
JAMA confirms DTC drove ‘Low-T’ craze – BioPharma Dive

Testosterone therapy has positive effects on anthropometric measures, metabolic syndrome components (obesity, lipid … – UroToday

To alleviate late-onset hypogonadism, testosterone treatment is offered to suitable patients. Although testosterone treatment is commonly given to late-onset hypogonadism patients, there remains uncertainty about the metabolic effects during follow-ups. We assessed the associations between testosterone treatment and wide range of characteristics that included hormonal, anthropometric, biochemical features. Patients received intramuscular 1,000mg testosterone undecanoate for 1year. Patient anthropometric measurements were undertaken at baseline and at each visit, and blood samples were drawn at each visit, prior to the next testosterone undecanoate. Eighty-eight patients (51.113.0years) completed the follow-up period. Testosterone treatment was associated with significant increase in serum testosterone levels and significant stepladder decrease in body mass index, total cholesterol, triglycerides and glycated haemoglobin from baseline values among all patients. There was no significant increase in liver enzymes. There was an increase in haemoglobin and haematocrit, as well as in prostate-specific antigen and prostate volume, but no prostate biopsy intervention was needed for study patients during 1-year testosterone treatment follow-up. Testosterone treatment with long-acting testosterone undecanoate improved the constituents of metabolic syndrome and improved glycated haemoglobin in a stepladder fashion, with no adverse effects.

Andrologia. 2017 Mar 10 [Epub ahead of print]

O Canguven, R A Talib, W El Ansari, D-J Yassin, M Salman, A Al-Ansari

Department of Urology & Andrology, Hamad General Hospital, Doha, Qatar., Department of Surgery, Hamad General Hospital, Doha, Qatar., Institute of Urology & Andrology, Norderstedt-Hamburg, Germany.

PubMed http://www.ncbi.nlm.nih.gov/pubmed/28295504

Follow this link:
Testosterone therapy has positive effects on anthropometric measures, metabolic syndrome components (obesity, lipid … – UroToday

Efficacy and safety of testosterone replacement gel for treating hypogonadism in men: Phase III open-label studies. – UroToday

Efficacy and safety of testosterone gel 2% (TG) were evaluated in two phase 3, open-labelled, single-arm, multicentre studies (000023 and extension study 000077). Hypogonadal men having serum testosterone levels 1500ng/dl, with no significant safety concerns. Significant improvements in sexual function and quality of life were noted in both studies. Subjects experienced few skin reactions without notable increases in prostate-specific antigen and haematocrit levels. TG was efficacious with an acceptable safety profile. Cmax >1500ng/dl did not exhibit distinct impact on safety parameters. However, further optimisation of titration schema to reduce Cmax is warranted while maintaining the average steady state total testosterone concentration.

Andrologia. 2017 Mar 10 [Epub ahead of print]

L Belkoff, G Brock, D Carrara, A Neijber, M Ando, J Mitchel

Urologic Consultants of Southeastern Pennsylvania, Bala Cynwyd, PA, USA., Division of Urology, Department of Surgery, Western University, London, ON, Canada., Ferring Galenisches Labor AG, Gewerbestrasse, Allschwil, Switzerland., International Pharma Science Center, Ferring Pharmaceuticals, Copenhagen, Denmark., Ferring International PharmaScience Center US Inc., Parsippany, NJ, USA., Target Health Inc, New York, NY, USA.

PubMed http://www.ncbi.nlm.nih.gov/pubmed/28295450

Here is the original post:
Efficacy and safety of testosterone replacement gel for treating hypogonadism in men: Phase III open-label studies. – UroToday

TRT and heart health: Conflicting findings published – ModernMedicine

Five recently published studies, including four from the National Institutes of Health-supported large-scale Testosterone Trials, provide new insight on testosterone replacement therapys effect on cardiovascular health, as well as anemia, cognitive function, and volumetric bone density and strength.

The effect of TRT on cardiovascular health in men with hypogonadism has been an unresolved issue considering the conflicting findings and design limitations of available research. Two of the new studies generated differing results, and while both studies had notable strengths, they had important weaknesses as well.

The Cardiovascular Trial of the Testosterone Trials (TTrials) was a prospective, randomized, double-blind, placebo-controlled study that included 170 men aged 65 years and older with hypogonadal symptoms and low testosterone (

Noncalcified coronary artery plaque volume determined by coronary computed tomographic angiography, a surrogate for coronary atherosclerosis, was investigated as the primary endpoint. Data from 138 men who completed the study showed the median plaque volume increased significantly more in the TRT-treated men compared with the control group (204 mm3 to 232 mm3 vs 317 mm3 to 325 mm3; estimated difference, 41 mm3, p=.003) (JAMA 2017; 317:708-16). Compared with controls, the TRT-treated group also had a significantly greater increase in total plaque volume, but there was no difference between groups in the change in coronary artery calcium score.

Related – Testosterone therapy’s big week: One urologist’s perspective

The strengths of the trial include its prospective, randomized design, selection of men with unequivocally low testosterone, and high retention rate. However, it used surrogate outcomes for cardiovascular events and was not of sufficient size or duration to investigate risk of major adverse cardiovascular events, said J. Kellogg Parsons, MD, MHS, of the University of California, San Diego, an investigator for the TTrials and a coauthor for previously published TTrials research. Larger studies are needed to understand the clinical implications of the radiologic findings.

Separately, researchers from Kaiser Permanente California analyzed cardiovascular event rates in a cohort of men age 40 years who had documented androgen deficiency (coded diagnosis or morning serum total testosterone

Multivariable Cox proportional hazard analysis using propensity score methodology to balance baseline characteristics found a 33% significantly reduced risk (p<.001 for the primary outcome cardiovascular endpoint including acute myocardial infarction coronary revascularization unstable angina stroke transient ischemic attack and sudden cardiac death in trt group compared with controls intern med epub. feb. result was similar additional analyses comparing risks all but one of individual events subgroups men years a event history without looking at defined follow-up intervals.>

T. Craig Cheetham, PharmD, MS, of Southern California Permanente Medical Groups department of research and evaluation, Pasadena, is lead author of the paper, which was not part of the TTrials. He told Urology Times, Our findings suggest that TRT is safe in androgen-deficient males. However, based on findings from previous studies, we believe caution is warranted when treating frail elderly males and those with high cardiovascular risk.

Commenting on the study design, Dr. Cheetham noted that its relatively large cohort of androgen-deficient men treated with TRT represents its major strength. In addition, the TRT-treated group was well matched to the control group, and the results were robust in the planned stratified and sensitivity analyses.

However, he acknowledged that because it was an observational study, the reported data only identify associations and cannot determine cause and effect. In addition, the study could not control for potential bias from unmeasured confounding.

Continued here:
TRT and heart health: Conflicting findings published – ModernMedicine

Family strength helps Brandon Ramirez persevere – Progress Index

Brandon Ramirez, 28, of Colonial Heights, has exceeded expectations with help from his mother and family

COLONIAL HEIGHTS Sitting in her dining room on a warm February afternoon, LaDonna DeStazio reflects on her familys journey that has led them to Colonial Heights. Her son, Brandon Ramirez, 28, sits beside her, confined to a special wheelchair. He was not expected to live past the age of 12.

It was emotionally hard, but never physically hard, said LaDonna DeStazio on having to care for her son. People used to say all the time gosh it must be so hard for you. You do what you do as a mom.

LaDonna has given Brandon round-the-clock care for many years of his life, as his condition has deteriorated.

He can use his voice sometimes, mentally hes all there, but physically he has declined, she said.

What Brandon Ramirez has is called 4H syndrome, a rare genetic disorder with only 40 known cases in the U.S. The name 4H is short for hypomyelination, hypogonadotropic hypogonadism, and hypodontia. According to the Leukodystrophy Resource and Research Foundation, hypomyelination means there is a lack of myelin in the central nervous system. Hypogonadotropic hypogonadism results in a lack of normal puberty development because the central nervous system is not working properly. Hypodontia means that not all teeth are present.

Symptoms of 4H include late walking, problems with balance and motor skills, and an absence of normal development during puberty. Due to the rarity of the syndrome, there is no known cure.

For the first decade of his life, doctors were unable to pinpoint Brandons disorder. LaDonna DeStazio first went to doctors in 1994 when Brandon was in kindergarten and he first started having tremors. Her family was living in Colorado at the time.

When we first took him to the doctors, they had no clue, said LaDonna. He was at the childrens hospital and they were doing all these tests. They said he had something called essential tremors.

When Brandon began struggling with his walking when he was 8, LaDonna took him back to the doctors.

At that point, thats when they said he had some form of vanishing white matter disease, said LaDonna.

Vanishing white matter refers to the deterioration of tissue in the brain, which is normally due to aging. Doctors told LaDonna that kids with that type of disease dont normally live past the age of 12. Despite the dire diagnosis, Brandon was still able to live a relatively normal childhood.

By the time he was 12, he really hadnt declined, said LaDonna. He was still able to ride a bike, his walking was fine. He did everything a normal kid could do, the only sign was really the gait when he walked.

At that point, when LaDonna took Brandon back to the doctors, they found no vanishing white matter. Doctors were again at a loss.

They were like We dont know what to tell you, we dont know what he has, said LaDonna. And at that point, I had done all this research, trying to figure out what the heck is going on with him, and was coming up with nothing. Nobody knew.

Brandon began to decline as he entered high school, as he had not properly gone through puberty due to the 4H. Despite his situation, Brandon was able to persevere with the help of his family and his mother, who attended school with him for the last three months before he graduated from Rangeview High School in Aurora, Colorado in 2007. Brandon was able to walk across the stage to receive his diploma. Brandon is proudly able to nod his head as his mother mentions that he had one of the highest SAT scores of all the students in his high school. Though despite the joy, he continued to worsen.

We were basically told in 2007 that he wouldnt make it, said LaDonna.

In 2008 after Brandon had declined to almost nothing according to LaDonna, she received an email from Dr. Adeline Vanderver of the Childrens National Health System in Washington D.C. Vanderver confirmed that the diagnosis that had eluded doctors was most likely 4H syndrome, and advised the family to relocate to the East Coast.

In the years after the diagnosis, Brandon was able to bounce back, even graduating from college with a degree in horticulture in 2009.

LaDonna having to move Brandon from Colorado coincided with her being introduced to Jeff DeStazio, who she met through a mutual friend. By then, LaDonna (who changed her last name from Ramirez) had been divorced from her first husband. Her other two children, Elizabeth and Anthony, are grown and still live in Colorado.

I really dont recall how it all happened. I needed to be on the East Coast: I basically called and was like Im coming to stay with you said LaDonna smiling. He was fresh off a divorce at the time, and I knew how to be a mom. So I would help him out with his girls.

LaDonna and Jeff were married in 2012. Along with Brandon, LaDonna and Jeff reside in their Colonial Heights home with Jeffs daughter Paige, who is 19. Jeffs other daughter Kylie is currently serving in the Marines.

The DeStazio household could certainly be described as unique. Two service dogs, Laychey and Bryndal, help Brandon with some of his day-to-day activities. Though the little puppies are not what you would normally tag as service dogs, with both of them being about a foot long and maybe 15 pounds. Brandons comfort kitties – Rizzie and Stash rest sleepily on his lap.

The DeStazios cant go out as much in recent years: LaDonna notes that car rides are a big thing, but the family still frequents occasional trips to goodwill and the mall. Brandon also enjoys watching the birds of local Buddy Waskey when he free-flies his Blue Throated Macaws. Paige DeStazio noted that she and Brandon often watch movies together.

I try to listen to music with him, and show him whats current, said Brandons cousin James Molica. Though its hard sometimes to tell what hes thinking.

Treating Brandon remains a challenge, as there is no set medication or treatment that works definitively for 4H.

A lot of it is still a guessing game, said LaDonna.

He has been taking testosterone and growth hormone on and off for many years. Brandon has also used a feeding tube at various times.

LaDonna also credits some Colonial Heights residents for assisting the family, as the ramp leading into the house and the stair chair that gets Brandon up the stairs were donated.

Despite the long road her family has taken, LaDonna firmly believes that the upbeat spirit they carry has led to Brandon reaching a point doctors never thought he would.

We chose to not let it be disruptive in our lives, said LaDonna. Not to let it change us as a family. We chose to focus on what he can do and not get depressed over the fact that oh Im not doing this.’

John Adam may be reached at jadam@progress-index.com or 804-722-5172.

Follow this link:
Family strength helps Brandon Ramirez persevere – Progress Index

USADA notifies Ben Rothwell of potential anti-doping violation, putting UFC 211 status in jeopardy – MMAjunkie.com


MMAjunkie.com
USADA notifies Ben Rothwell of potential anti-doping violation, putting UFC 211 status in jeopardy
MMAjunkie.com
Doctors told me TRT was something that could stop the hypogonadism from degrading my body, he wrote in a statement to MMAjunkie at the time. I am not going to fight the suspension as I feel ultimately it is my responsibility to make sure I stay

and more »

Originally posted here:
USADA notifies Ben Rothwell of potential anti-doping violation, putting UFC 211 status in jeopardy – MMAjunkie.com

Declining libido? This may be the cause – Bel Marra Health

Home Men’s Health Declining libido? This may be the cause

Contrary to popular belief, menopause is not just a female problem. Male menopause the nickname for late-onset hypogonadism that occurs as a mans testosterone levels wane with age can mimic its female counterpart and include symptoms such as hot flashes, disrupted sleep, fatigue, and flagging libido, as well as moodiness.

Low testosterone levels affect as much as 25 percent of middle-aged men, making the condition more common than it may seem. However, unlike the rapid changes women experience, the decline in testosterone happens more gradually which can make symptoms difficult to spot and attribute to the correct cause. Being more tired and not sleeping well may lead you to think that you need a new mattress or should cut back on the caffeine. Because of hot flashes, you may think the room is warmer or youre coming down with a fewer. And your flagging libido could potentially be related to that fatigue or increased stress. (Siberian secret refuels energy from within.)

As these symptoms are all so general and easy to overlook, hypogonadism (insufficient production of testosterone) can be overlooked and leave its sufferers confused and agitated. Luckily, a simple blood test performed by your doctor will tell you if your testosterone levels are lower than average, and there are treatments available to get your levels back to where they should be to relieve symptoms.

However, these treatments have proven most effective in men who have been diagnosed with conditions like testicular cancer and the merit of treating men with low testosterone due to aging is still up for debate. In the guidelines released by the Endocrine Society, it is recommended that physicians only prescribe medical testosterone therapy for men who are experiencing consistently low levels, and significant sexual and physical complications. (Boost your testosterone naturally with this one thing.)

Related: 5 sure-fire ways to boost your libido

Related Reading:

Low libido? It could be something more serious

Spark your libido with these 6 fixes

http://www.health.com/health/condition-article/0,,20408367,00.html

Read more here:
Declining libido? This may be the cause – Bel Marra Health

Denosumab is really effective in the treatment of osteoporosis secondary to hypogonadism in prostate carcinoma … – UroToday

Osteoporosis is a complication of androgen deprivation therapy (ADT) in men with prostate carcinoma. The best defense against osteoporosis in prostate cancer is to identify patients with a high risk for fracture during the first clinical visit, select an effective anti-osteoporosis agent, and advise the patient to change his lifestyle and diet to prevent further bone loss. New agents include denosumab, a human monoclonal antibody that inhibits the RANK ligand (RANKL). RANKL promotes the formation, activity, and survival of osteoclasts and, thus, supports the breakdown of bone.

This is a multicenter, randomized, double-blind prospective study on use of denosumab versus alendronate in the therapy of secondary osteoporosis related to ADT in prostate cancer patients in three European countries (Italy, France, Switzerland).

In this 24-month observation study we enrolled 234 patients with diagnosis of osteoporosis underwent ADT for prostate cancer. All patients aged 55 years and had a dual-energy X-ray absorptiometry (DEXA) T-score

In our study denosumab and alendronate showed similar clinical efficacy in the therapy of ADT-related osteoporosis in men with prostate carcinoma; both drugs provided significant improvements in back pain and general health conditions. Denosumab showed significant increase of BTMs and BMD than alendronate with lower rate of new vertebral fractures.

Clinical cases in mineral and bone metabolism : the official journal of the Italian Society of Osteoporosis, Mineral Metabolism, and Skeletal Diseases. 2017 Feb 10 [Epub]

Carlo Doria, Paolo Tranquilli Leali, Federico Solla, Gianluca Maestretti, Massimo Balsano, Robero Mario Scarpa

Orthopaedic Department, University of Sassari, Italy., Orthopaedic Department, Paediatric Hospital Nice CHU-Lenval, France., Spinal Unit – Cantonal Hospital Fribourg, Switzerland., Orthopaedic Department, Santorso Hospital AUSSL 4 Schio, Italy., University of Turin, Italy.

PubMed http://www.ncbi.nlm.nih.gov/pubmed/28228781

Go here to see the original:
Denosumab is really effective in the treatment of osteoporosis secondary to hypogonadism in prostate carcinoma … – UroToday

Increased Plaque Volume on CCTA in Older Men Who Use Testosterone Gel – Diagnostic Imaging

News | March 01, 2017 | Cardiac Imaging, CT

Coronary CT angiography (CCTA) shows older men who use testosterone gel have a significantly greater increase in coronary artery noncalcified plaque volume, according to a study published in the Journal of the American Medical Association.

Researchers from nine states in the U.S. undertook a double-blinded, placebo-controlled trial to determine if testosterone use among older men slowed progression of noncalcified coronary artery plaque volume or increased cardiovascular risk.

A total of 138 men completed the study out of 170 who enrolled. The men were aged 65 or older with an average of two serum testosterone levels lower than 275 ng/dL and had symptoms suggestive of hypogonadism. The subjects received testosterone gel dose adjusted to maintain the testosterone level in the normal range for young men (73 subjects), or placebo gel for 12 months (65 subjects).

The primary outcome was noncalcified coronary artery plaque volume, as determined by CCTA, and secondary outcomes included total coronary artery plaque volume and coronary artery calcium score (range of 0 to more than 400 Agatston units, with higher values indicating more severe atherosclerosis). At baseline, 70 men (50.7%) were found to have a coronary artery calcification score higher than 300 Agatston units, reflecting severe atherosclerosis.

Coronary CT angiogram results showed testosterone treatment compared with placebo was associated with a significantly greater increase in noncalcified plaque volume from baseline to 12 months, from median values of 204 mm3 to 232 mm3 versus 317 mm3 to 325 mm3, respectively, with an estimated difference of 41 mm3. For the secondary outcomes, the median total plaque volume increased from baseline to 12 months from 272 mm3 to 318 mm3 in the testosterone group versus from 499 mm3 to 541 mm3 in the placebo group, with an estimated difference of 47 mm3. The median coronary artery calcification score changed from 255 to 244 Agatston units in the testosterone group versus 494 to 503 Agatston units in the placebo group, with an estimated difference of 27 Agatston unit. No major adverse cardiovascular events occurred in either group.

The researchers concluded that older men with symptomatic hypogonadism who undergo treatment with testosterone gel for one year have a significantly greater increase in coronary artery noncalcified plaque volume. Larger studies are needed to understand the clinical implications of this finding, they wrote.

View post:
Increased Plaque Volume on CCTA in Older Men Who Use Testosterone Gel – Diagnostic Imaging

Topical testosterone replacement gel therapy safe, effective in hypogonadism – Healio

Topical testosterone replacement gel therapy safe, effective in hypogonadism
Healio
Men with hypogonadism using a topical testosterone replacement gel therapy administered with a hands-free cap applicator reported high satisfaction with the treatment and had improved testosterone levels, according to published data.

Read the original post:
Topical testosterone replacement gel therapy safe, effective in hypogonadism – Healio

Antares Pharma Announces FDA Acceptance of New Drug Application for Quickshot Testosterone – P&T Community

Antares Pharma Announces FDA Acceptance of New Drug Application for Quickshot Testosterone
P&T Community
We continue to believe QST could be an excellent treatment option for men with hypogonadism based upon the positive pharmacokinetic and safety data produced in the two phase three studies now on file with the FDA. In addition to virtually eliminating

and more »

More here:
Antares Pharma Announces FDA Acceptance of New Drug Application for Quickshot Testosterone – P&T Community

8 things you need to know about testosterone and ‘the male menopause’ – Netdoctor

Testosterone is more than just a sex hormone. Its role goes beyond giving pubescent boys growth spurts, and its effects on the male body are lifelong. But talk of a male menopause, marked by reduced testosterone from middle age, is often met with controversy.

Here are a few things you might not know about men and testosterone:

Testosterone plays a part in maintaining muscle mass, physical energy and mental alertness, as well as libido and sexual stimulation . Since these characteristics are associated with youth, it’s no surprise that men produce gradually less testosterone as they age. The rate of decline varies, but levels typically drop by around 20 to 50 per cent between early adulthood when they are at their peak and when a man reaches his 80s .

ADVERTISEMENT – CONTINUE READING BELOW

The medical term for low testosterone in men is ‘male hypogonadism’. It can be caused by problems with the testicles, for example resulting from infection, chemotherapy, certain autoimmune conditions and some tumours.

It can also signal a condition affecting the pituitary gland, which sits at the bottom of the brain stem. If the function of the pituitary gland becomes impaired through a head injury, tumour or using anabolic steroids, for example it has a knock-on effect on certain hormones, which in turn means the testicles don’t make as much testosterone.

Related Article

5 hidden links between illnesses you should be aware of

Professor Mike Kirby, a GP and visiting professor to the Prostate Centre, says that as they get older, men develop more long-term conditions “such as diabetes, metabolic syndrome and cardiovascular disease and all those things impact on testosterone levels”.

Being overweight or obese, also more common in older than in younger men, is also linked with hypogonadism.

So, although it’s normal for testosterone levels to fall a certain amount as men get older, the ageing process itself doesn’t ordinarily cause testosterone to dip beneath the lower end of normal range. Other health problems are responsible for almost all cases of reduced testosterone in older men, and that, says consultant endocrinologist Dr Richard Quinton, negates the concept of a male menopause. He says:

“For a tiny minority, there is a slightly similar phenomenon to the female menopause, but it’s mild and partial rather than complete and absolute.”

When a man’s testosterone levels are low, he’ll often get quite vague symptoms. As well as a change in the sex department loss of libido and erectile dysfunction he might experience difficulty concentrating, insomnia, mood disturbances, weight gain and loss of muscle bulk.

These signs are all-too-easy to ignore, but Dr John Chisholm CBE, a GP and chair of the Men’s Health Forum, urges men to get them checked:

“Erectile dysfunction in particular should be looked into because it can be a symptom of serious underlying disease.”

Getty Tetra ImagesMore

ADVERTISEMENT – CONTINUE READING BELOW

Low testosterone levels can be confirmed by a blood test, and the standard treatment is testosterone replacement by way of a tablet, patch, gel, implant or injection . Evidence suggests that with regular monitoring, testosterone treatment is safe, effective and relatively free of side effects when it’s prescribed appropriately .

The problem is that experts disagree about who should be prescribed testosterone. Professor Kirby argues that men with the lowest levels of testosterone level will “almost certainly benefit from treatment regardless of the cause” and that in men whose levels are at the lower end of normal, “it may well be worth addressing the cause first, but some would still benefit from testosterone treatment”.

But others, including Dr Quinton, dispute this. He supports treatment only in men who are “genuinely hypogonadal” in other words, those who have consistently low testosterone but aren’t obese and have no underlying illness.

“Giving testosterone to men who are either normal, or just have hypogonadism due to chronic ill health including obesity cannot be justified on the basis of available safety and efficacy data.”

As well as restoring testosterone levels, testosterone treatment slows the production of certain hormones, switching off sperm production in the testicles. Alternative hormone treatments can work for younger men and those who want to maintain their fertility.

The clear message is that if you’re worried about anything, talk to your doctor. The chances are symptoms are nothing to worry about and any problems can be easily rectified

“We’d also recommend they seek help if they’re experiencing mental health disturbance. It’s better to talk than to avoid issues and conceal symptoms.”

Related Article

Rambling speech could be a precursor for dementia, study suggests

See the original post here:
8 things you need to know about testosterone and ‘the male menopause’ – Netdoctor

A study to evaluate the prevalence of hypogonadism in Indian males with Type-2 diabetes mellitus. – UroToday

A high prevalence of hypogonadism in men with Type-2 diabetes mellitus (T2DM) has been reported worldwide.

To evaluate the prevalence of hypogonadism in Indian males with T2DM and assess the primary and secondary hypogonadism along with androgen deficiency.

In this cross-sectional study, 900 men with T2DM were evaluated using androgen deficiency in aging male questionnaire. They were screened for demographic characteristics, gonadal hormone levels, lipid profile, and glycosylated hemoglobin.

The prevalence of hypogonadism in T2DM patients was found to be 20.7% (186 out of 900). Hypogonadism was of testicular origin (primary) in 48/186 (25.8%) patients, of pituitary or hypothalamic origin (secondary) in 14/186 (7.53%), and remaining 124/186 (66.67%) patients were found to have low testosterone with the inappropriate normal level of luteinizing hormone and Follicle-stimulating hormone. 451/900 (50.1%) patients were only symptomatic but had normal testosterone levels. Further 263 patients out 900 were asymptomatic, of which 51/900 (5.7%) patients had low levels of testosterone and 212/900 (23.5%) patients had normal testosterone level without symptoms. There were no deaths or other serious adverse events except mild pyrexia which was not related to the study.

Hypogonadism diagnosis, at times, might not be validated with the help of androgen deficiency questionnaire or symptoms only. Given the large number of patients of T2DM in India, the incidence of hypogonadism is more in diabetic patients as compared to the general population. Hence, implementation of screening programs in diabetic patients is necessary to understand and detect individuals with low serum total testosterone at any early stage and to supplement testosterone accordingly.

Indian journal of endocrinology and metabolism. 0000 Jan [Epub]

Pankaj Kumar Agarwal, Parminder Singh, Subhankar Chowdhury, S K Sharma, Anirban Majumdar, Parag Shah, Rakesh Sahay, S Vageesh Ayyar, Hemant Phatale, Chandar M Batra, Raeesuddin Syed, Pradeep Shetty

Hormone Care and Research Center, Near St. Mary’s School, Ghaziabad, Uttar Pradesh, India., Department of Endocrinology, Dayanand Medical College and Hospital, Civil Lines, Ludhiana, Punjab, India., Department of Endocrinology, IPGME&R and SSKM Hospital, Ronald Ross Building, 4th Floor, 244, A J C Bose Road, Kolkata, West Bengal, India., Thyroid and Endocrine Centre, Near 4 No. ESI Hospital, Jaipur, Rajasthan, India., Thyroid and Hormone Clinic, Dhakuria, Kolkata, West Bengal, India., Gujarat Endocrine Centre, 2nd Floor, Silver Brook B, Opposite Doctor House, Near Parimal Crossing, Ahmedabad, Gujarat, India., Department of Endocrinology, Osmania General Hospital, 2nd Floor, Golden Jubilee Block, Afzalgunj, Afzalgunj, Hyderabad, Telangana, India., Department of Endocrinology, St. John’s Medical College and Hospital, Bengaluru, Karnataka, India., Samrat Endocrine Institute of Diabetes, Obesity and Thyroid, Aurangabad, Maharashtra, India., Department of Endocrinology, Sarita Vihar, Delhi Mathura Road, New Delhi, India., Global Medical Affairs, MSD Pharmaceuticals Private Limited, 10th Floor, Platina Building, C-59, G-Block, Bandra Kurla Complex, Mumbai, Maharashtra, India.

PubMed http://www.ncbi.nlm.nih.gov/pubmed/28217500

More here:
A study to evaluate the prevalence of hypogonadism in Indian males with Type-2 diabetes mellitus. – UroToday

Testosterone treatment and coronary artery plaque volume in older men with low testosterone – Pharmacy Today, American Pharmacists Association,…

A new study suggests that treatment with testosterone is linked with a significantly higher increase in coronary artery noncalcified plaque volume in older men with symptomatic hypogonadism. The placebo-controlled trial, conducted at nine academic medical centers in the United States, included 138 men aged 65 years or older with an average of 2 serum testosterone levels lower than 275 ng/dL and symptoms suggestive of hypogonadism in the primary analysis. Of those men, 73 received testosterone treatment and 65 received placebo; and 70 overall had a coronary artery calcification score indicative of severe atherosclerosis. For the primary outcome, testosterone treatment was associated with a significantly greater increase in noncalcified plaque volume from baseline to 1 year, compared with placebo. Additionally, treatment was associated with increased total plaque volume, though not with changes in coronary artery calcium score. No major adverse cardiovascular events occurred in either of the groups. To better understand the clinical implications of the findings, the researchers note that larger studies are needed.

Read more from the original source:
Testosterone treatment and coronary artery plaque volume in older men with low testosterone – Pharmacy Today, American Pharmacists Association,…

New studies fail to change ‘unfavorable balance’ of risks/benefits of testosterone supplements – MinnPost

The only male medical condition that testosterone supplements have been shown to clearly help is hypogonadism abnormally low levels of the hormone that result from a disorder of the hypothalamus, pituitary gland or testes.

But thats a relatively small market for such drugs. Hypogonadism affects only 0.1 percent of men in their 40s and just 5.1 percent of men in their 70s. So, about two decades ago, pharmaceutical companies hit upon a grand idea: They would get doctors to expand the definition of low testosterone to include any middle-aged or older man with somewhat lower testosterone levels (a drop that occurs naturally with age) as well as common age-related complaints, such as fatigue, sleep problems, weight gain, and decreased libido or physical abilities.

This medicalization of male aging, which began about a decade ago, worked. Sales of testosterone supplements for Low T skyrocketed, increasing tenfold in the United States between 2000 and 2011.

Researchers have been playing catch-up ever since, trying to figure out if testosterone supplements whether gels, patches, pills or other products really live up to all the marketing hype. In 2003, the National Academy of Medicine (then the National Institute of Medicine) called for more rigorous research to look at both the positive and negative health effects of testosterone replacement therapy in older men.

So far, concerns about the drugs have tended to heavily outweigh any claims of benefits. Indeed, in 2015, the U.S. Food and Drug Administration required the products labels to carry warnings that their use is associated with an increased risk of heart disease and stroke.

A series of new studies is unlikely to ease those concerns. The studies examined the effect of testosterone supplements on the bone health, anemia status, memory skills and cardiovascular health of older men.

Four of the studies used data from the Testosterone Trials (TTrials), which involved 790 men aged 65 and older. Half of the men were randomly assigned to take a daily dose of testosterone in the form of a gel for a year, while the others took a placebo for the same period of time. (The gel raised the mens testosterone to levels that tend to occur in healthy, younger men.)

The results were published Tuesday in the Journal of the American Medical Association (JAMA) and JAMA Internal Medicine:

Those three studies could be viewed as neutral or even mildly promising for testosterone supplements. But the same cant be said of the fourth study the one on cardiovascular health.

Its findings suggest that testosterone supplementation may raise the risk of heart disease. The men in the study who were using the testosterone gel experienced a significantly greater buildup of plaque in their arteries compared to the men who were taking the placebo. Arterial plaque is considered an early sign of heart disease.

The study was small, however, and followed the men for only a year. A larger, longer study would be needed to confirm the findings.

A fifth study, which was also published Tuesday in JAMA Internal Medicine but which was not part of the TTrials, also looked at the association between testosterone supplementation and cardiovascular outcomes, this time in more than 8,000 men aged 40 or older with low T levels of the hormone. It found that the supplementation was associated with a lower risk of stroke, angina and other heart-related outcomes.

But that study was an observational one, which means its findings do not prove that the testosterone treatments were related to the better heart outcomes. Many associations that emerge from observational studies vanish once they are tested in clinical trials.

Overall, the findings from these studies do not materially change the unfavorable balance of safety and efficacy to initiate testosterone treatment for age-related declines in the hormone, writes David Handelsman, a reproductive endocrinologist at the University of Sydney, in an editorial that accompanies the study. Rather, low testosterone levels due to obesity and other aging comorbidities are better addressed by lifestyle measures directed at those comorbidities.

Handelsman then takes the medical profession to task, noting that testosterone overprescribing has been propelled not only by direct-to-consumer advertising, but also with the complicity of some professional organizations and physicians that have supported redefinition of the term hypogonadism through permissive guidelines appearing to minimize the fundamental distinction between pathological hypogonadism and age-related, low circulating testosterone.

Those guidelines need to be revised, he stressed, to remove their tacit, uncritical endorsement of testosterone supplements as a panacea for male aging.

Hopes for hormonal rejuvenation appear periodically throughout history, he writes, but with the results of the studies published on Tuesday, the hopes for testosterone-led rejuvenation for older men are dimmed and disappointed if not yet finally dashed.

FMI: Youll find all the studies mentioned and the editorial in the Feb. 21, 2017, issues of JAMAand JAMA Internal Medicine.

Go here to see the original:
New studies fail to change ‘unfavorable balance’ of risks/benefits of testosterone supplements – MinnPost

Studies show testosterone offers little benefits to aging men – Ars Technica

The testosterone gel used in a series of trials assessing health effects.

In decades of research, scientists have found only one medical condition thats clearly and effectively treated with testosterone supplements: pathological hypogonadismthats low testosterone levels due to disease of the hypothalamus, pituitary gland, or testes.

But that hasnt stopped drug makers and the supplement industry from convincing men that jacking their testosterone will stave off the effects of aging. Getting old naturally lowers testosterone in the body. In efforts to combat Low T, testosterone sales sprung 10-fold in the US between 2000 and 2011.

In light of that trend, researchers are trying to get a handle on the health benefits of that beefed-up hormone consumption. So far, it looks wimpy.

In a series of placebo-controlled, randomized trials, researchers tracked the effect of testosterone on the cognition, bone health, anemia, and cardiovascular health of 788 men for a year. All the men were aged 65 or older and had low testosterone levels that couldnt be explained by anything other than age.

The results, reported Tuesday in JAMA and JAMA Internal Medicine, offer mixed results.

Among the 493 in the trial who also had age-related memory declines, testosterone didnt have any effect on memory or cognitive abilities. In the study, 247 got testosterone and 246 got a placebo.

But for cardiovascular health, there was an effecta bad one. Over the year,plaque buildup in the coronary arterywhich is a risk factor for heart diseaseincreased in 73 men on testosterone compared with 65 on placebo. However, other studies have found mixed results on this. Longer, bigger trials will be needed to sort out the risks.

In the anemia study, testosterone did seem to improve iron levels in men with mild anemia. The bone health study also showed that testosterone could improve bone density.

However, its unclear if those benefits outweigh the possible cardiovascular risks. And other drugs may be more effective at treating anemia and improving bone mass than testosterone.

In anaccompanying editorial, Dr. David Handelsman of the University of Sydney and Concord Hospital in Australia concluded that the overall findings do not materially change the unfavorable balance of safety and efficacy to initiate testosterone treatment for age-related hypogonadism. Thus, he added, the hopes for testosterone-led rejuvenation for older men are dimmed and disappointed if not yet finally dashed. But health experts and medical societies should revise guidelines and recommendation to best inform patients, he argued.

Testosterone misuse will not simply disappear for lack of logic or evidence as none was needed to get it startedrejuvenation fantasies thrive on hope without needing factsand educational efforts are essential.

See original here:
Studies show testosterone offers little benefits to aging men – Ars Technica

Testosterone therapy may help prevent heart disease – Bel Marra Health

Home Men’s Health Testosterone therapy may help prevent heart disease

Recent research published in the Journal of Cardiovascular Pharmacology and Therapeutics has revealed that long-term testosterone therapy (TTh) for males who have hypogonadism (or testosterone deficiency) may also help prevent cardiovascular (CV) disease. Testosterone (T) is the main male sex hormone and is responsible for the development of male reproductive tissuesit also encourages muscle, bone, and body hair growth. Males with a testosterone deficiency are at risk for developing osteoporosis, as insufficient levels contribute to weakness and bone loss.

Researchers followed two groups of men for eight years for an observational study to determine whether testosterone therapy had an effect on the risk of cardiovascular disease. The first group had been treated with testosterone therapy for their hypogonadism, while the second group had not. After the eight years, only two men from the first group had died, and neither instance was related to cardiovascular disease.

In contrast, there were 21 deaths in the second group, 19 of which were caused by cardiovascular-related events. This group also saw 26 non-fatal myocardial infarctions or heart attacks, and 30 non-fatal strokes, while the first group experienced none. Based on these results, the team concluded that long-term testosterone therapy for men with hypogonadism may be an effective method to help improve cardiometabolic function and reduce the risk of cardiovascular disease and related events.

These results show that there may be a protective benefit gained when treating hypogonadal males with long-term testosterone therapy, and with further research, it may be utilized to help prevent cardiovascular disease and events, as well as to treat testosterone deficiency.

Related Reading:

Heart disease risk in men linked to high testosterone and low estrogen

Testosterone may be linked to hardening of blood vessels associated with heart disease: Study

https://www.eurekalert.org/pub_releases/2017-02/bumc-ttp021317.php

Visit link:
Testosterone therapy may help prevent heart disease – Bel Marra Health

Latest Research Predicts Endocrinology Drugs Market in Nascent Stage set for advancing growth by 2021 – Satellite PR News (press release)

Submit the press release

Endocrinology Drugs MarketResearch Report covers the present scenario and the growth prospects of the Endocrinology Drugs Industry for 2016-2020. Endocrinology Drugs Market, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years and discussion of the key vendors effective in this market. To calculate the market size, the report considers the revenue generated from the sales of Endocrinology Drugs globally.

For further information on this report, please visit-http://www.marketreportsworld.com/10278756

The Endocrinology Drugs Market report contains a comprehensive market and vendor landscape in addition to a SWOT analysis of the key vendors. The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. Following Companies Are Key Players of the Endocrinology Drugs Market:

Other Prominent Vendors of Endocrinology Drugs Market Are:

As vendors are facing the problem of a decline in venture capital investment, they are increasingly following the strategy of outsourcing. Different parts of research such as product characterization testing and toxicology testing are outsourced to third-party research organizations. Similarly, some vendors outsource the pharmaceutical product manufacturing or the entire manufacturing process to contract manufacturing organizations. This reduces the operational costs, as most companies do not have to maintain expensive R&D laboratories and scientists. Pharmaceutical companies rely on the contract manufacturing organizations based in India, China, Russia, and Eastern Europe to manufacture and process their products.

Ask Sample PDF of Endocrinology Drugs Market Report @http://www.marketreportsworld.com/enquiry/request-sample/10278756 According to the Endocrinology Drugs Market report, the increase or decrease in the release of endocrine hormones leads to disorders such as diabetes, hypogonadism, hypothyroidism, and hyperthyroidism. The prevalence of diabetes is rising because of obesity, unhealthy diet, and lack of physical activity among individuals. The prevalence of hypogonadism also increases in men with diabetes, human immunodeficiency virus (HIV), chronic obstructive pulmonary disease, heart or renal disease, or in individuals who are on opiate or glucocorticoid therapy. Thus, the increase in the prevalence of these diseases will lead to the increase in the intake of medications, propelling the market growth. Report also presents Geographical Segmentation analysis of Endocrinology Drugs Market of Americas, APAC, EMEA region.

For Any Query, Contact Our Expert@http://www.marketreportsworld.com/enquiry/pre-order-enquiry/10278756 Further, the Endocrinology Drugs Market report states that the patent expiry of major approved drugs is expected to impact the market adversely and slow down its growth during the forecast period.

Key questions answered in Endocrinology Drugs market report:

No of Pages: 118

Price of Report:$ 2500 (Single User License)

Purchase Report @http://www.marketreportsworld.com/purchase/10278756

About Market Reports World:

Market Reports World is the credible source for gaining the market research reports that will exponentially accelerate your business. We are among the leading report resellers in the business world committed towards optimizing your business. The reports we provide are based on a research that covers a magnitude of factors such as technological evolution, economic shifts and a detailed study of market segments.

Contact

Mr. Ameya Pingaley

Market Reports World

+1 408 520 9750

Email sales@marketreportsworld.com

http://www.marketreportsworld.com

See more here:
Latest Research Predicts Endocrinology Drugs Market in Nascent Stage set for advancing growth by 2021 – Satellite PR News (press release)

Testosterone therapy provides protection against cardiovascular disease in men with low testosterone – Science Daily

Despite the continued controversy surrounding the use of testosterone in men who have testosterone deficiency (hypogonadism), a new study has found that long-term use of testosterone therapy not only improves vigor and vitality, but may reduce the risk of death due to cardiovascular (CV) disease.

These findings appear online in the Journal of Cardiovascular Pharmacology and Therapeutics.

Testosterone (T) is the primary male sex hormone. In men, T plays a key role in the development of male reproductive tissues as well as promoting secondary sexual characteristics such as increased muscle and bone mass and growth of body hair. In addition, T is essential for overall health and well-being and for the prevention of osteoporosis. Insufficient levels of circulating T in men, contributes to frailty and bone loss.

In the absence of large, prospective, placebo-controlled clinical trials of longer duration, substantial evidence regarding the safety and risk of testosterone therapy (TTh) with regard to cardiovascular outcomes can only be gleaned from observational studies. To date, there are limited studies comparing the effects of long-term TTh in hypogonadal men who were treated or remained untreated with T.

Researchers at Boston University Schools of Medicine (BUSM) and Public Health (BUSPH), along with researchers in Germany, established a registry to assess long-term effectiveness and safety of T in men. For this study, they sought to compare its effects on a host of parameters (obesity, cholesterol levels, diabetes, liver function) considered to contribute to cardiovascular disease.

The researchers followed a group of men for eight years who had been on TTh and compared them with another group of men who remained untreated for the same time period. They found there were only two deaths in the TTh group and neither was related to CV events. In the non-treated control group, there were 21 deaths, 19 of which were related to CV events. Furthermore, there were 26 non-fatal myocardial infarctions and 30 non-fatal strokes in the control group but none in the T-treated group.

According to the researchers, long-term TTh in men with hypogonadism appears to be an effective approach to achieve sustained improvements in cardiometabolic function and reduces the risk of CV events. “The low CV events observed in the T-group compared to the untreated (control) group strongly suggest that TTh is protective. We believe that the protective effect of T on the CV system provides clinicians with the opportunity to utilize this approach for secondary prevention for hypogonadal men with a history of CV events,” explained corresponding author Abdulmaged M. Traish, PhD, professor of biochemistry and urology at BUSM.

Story Source:

Materials provided by Boston University Medical Center. Note: Content may be edited for style and length.

Continue reading here:
Testosterone therapy provides protection against cardiovascular disease in men with low testosterone – Science Daily

Hypogonadism in Reproductive Years – Renal and Urology News

Hypogonadism in Reproductive Years
Renal and Urology News
Hypogonadism in Reproductive Years. An obese 43-year-old male presents for evaluation of primary infertility and loss of libido. His wife is 37 and has regular periods but has moderate premature ovarian failure. Aside from the obesity, the physical …

See original here:
Hypogonadism in Reproductive Years – Renal and Urology News

Low Testosterone Products Litigation – US Recall News (press release)


US Recall News (press release)
Low Testosterone Products Litigation
US Recall News (press release)
Between 3 and 7 percent of the male population in the US develop hypogonadism. One of the symptoms of this condition is a testosterone deficiency. Other symptoms include fatigue and low libido. Testosterone products were the go-to medication for men …

View post:
Low Testosterone Products Litigation – US Recall News (press release)

Posters to Be Presented at the Endocrine Society 2017 Annual Meeting – Business Wire (press release)

TORONTO–(BUSINESS WIRE)–Acerus Pharmaceuticals Corporation (TSX:ASP) announces the acceptance of two posters highlighting the clinical benefits of NATESTO for presentation at the Endocrine Society 2017 Annual Meeting (ENDO) to be held on April 1-4, 2017 in Orlando, Florida. Both abstracts will also be published in future issues of Endocrine Reviews. Developed by Acerus, NATESTO is the first and only testosterone nasal gel available in Canada and the US indicated for androgen replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism).1

The acceptance of these posters, in addition to the two abstracts accepted for presentation at the American Urology Association Annual Meeting announced last month, further expands the body of evidence in support of NATESTO, said Tom Rossi, Chief Executive Officer of Acerus Pharmaceutical Corporation.

The following summarizes the two abstracts accepted for presentation at ENDO:

Title: Seasonal Allergies Do Not Significantly Impact the Absorption of NATESTO (Testosterone) Nasal Gel in Hypogonadal Men Abstract-ID: 32092 Presenter: Alan Rogol, MD, PhD, Professor, University of Virginia, Charlottesville, VA Conclusions: The pharmacokinetics, safety and efficacy of NATESTO for restoring normal testosterone levels in men with Low T is not adversely affected by seasonal allergies.

Title: One-Year Hematologic Safety of NATESTO (Testosterone) Nasal Gel in Men with Hypogonadism Abstract-ID: 32161 Presenter: Margaux Guidry, Ph.D. and Gerwin Westfield, Ph.D., both Aytu Bioscience, Englewood, CO Conclusions: Treatment with NATESTO helped hypogonadal men achieve normal testosterone levels, while on average keeping hematologic levels, particularly hematocrit, well within the normal range.

About NATESTO(Testosterone) Nasal Gel

NATESTO is a testosterone nasal gel developed by Acerus Pharmaceutical Corporation and indicated as a replacement therapy for men diagnosed with conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). It is the first and only nasally-administered testosterone product approved by the U.S. FDA and Health Canada, and available in a no-touch dispenser with a metered dose pump for reduced transference risk. The recommended starting dose of NATESTO in Canada is 11 mg of testosterone (one actuation per nostril) administered twice daily for a total daily dose of 22 mg. A copy of the NATESTO product monograph can be found at: http://www.aceruspharma.com/English/products-and-pipeline/NATESTO/default.aspx.

For further information, specific to the U.S. product dosing and administration, please visit: http://www.NATESTO.com.

About Acerus

Acerus Pharmaceuticals Corporation is a Canadian pharmaceutical company focused on the development, manufacture, marketing and distribution of innovative, branded products that improve the patient experience.

Acerus currently markets two products in Canada: ESTRACE,a product indicated for the symptomatic relief of menopausal symptoms; and NATESTO, the first and only testosterone nasal gel for testosterone replacement therapy in adult males diagnosed with hypogonadism. Acerus pipeline includes two new innovative products: GYNOFLOR, an ultra-low dose vaginal estrogen combined with a probiotic, used in the treatment of atrophic vaginitis, restoration of vaginal flora and treatment of certain vaginal infections; and TEFINA, a use as required drug development candidate, aimed at addressing a significant unmet need for women with female sexual dysfunction.

For more information, visit http://www.aceruspharma.com and follow us on Twitter and LinkedIn.

Notice regarding forward-looking statements

Information in this press release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information are assumptions regarding our future operational results. These assumptions, although considered reasonable by the company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the company is subject to a number of risks and uncertainties, and could differ materially from what is currently expected as set out above. For more exhaustive information on these risks and uncertainties you should refer to our annual information form dated March 1, 2016 that is available at http://www.sedar.com. Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.

References:

1. NATESTO Product Monograph, October 25, 2016 and Rogol et al. J Andrology 2015, 4(1), 46

Original post:
Posters to Be Presented at the Endocrine Society 2017 Annual Meeting – Business Wire (press release)

Archives