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MetP Pharmas patent application for a new method to treat demyelinating and neuroinflammatory diseases, including multiple sclerosis (MS), has been approved by the United States Patent and Trademark Office (USPTO).

The patent, titled Treatment of Demyelinating Diseases (U.S. Appl. No. 16/506,830), is valid until 2039, andcovers the use of a steroid hormone, such as testosterone, in combination with a Hedgehog pathway modulator.

Steroid hormonesare a class of hormones defined by a particular molecular structure, and they play a variety of important roles throughout the body. Testosterone, in particular, is best known for its role in male sex development, but it also plays roles in the regular functioning of the brain, and has beenproposedas a therapeutic target for demyelinating diseases (those characterized by the loss of myelin, the protective coat of neurons). MS is a demyelinating disease.

The hedgehog pathway (named for the way flies with mutations in these genes look) is a molecular pathway through which cells transmit information to each other. It is best known for its importance in the development of numerous organ systems, including the brain, and also has been implicated to play a role in protecting neurons from demyelination.

Research suggesting that treatment with testosterone, together with a compound that modulates (changes the activity of) the hedgehog pathway, can drive remyelination and promote neural repair is the basis of the new patent.

The patent broadly covers the use of this therapeutic approach in demyelinating and inflammatory diseases of the nervous system, including MS, amyotrophic lateral sclerosis (ALS),Devics disease, Alzheimers disease, Guillain-Barr syndrome, and chronic inflammatory demyelinating polyneuropathy.

The patent covers any route of administration, favoring nasal spray. It also allows the administration of the two components together, one at a time, or some variation thereof.

According to MetP Pharma, this new therapeutic approach offers a new regenerative strategy with the potential of repairing already damaged myelin, whereas current therapeutic strategies lack an efficient regenerative potential.

Most medications used to treat MS are generally ineffective in progressive forms that are characterized by a chronic demyelination of axons. This new method can tremendously boost the remyelination of abnormal axons, and therefore may help to treat demyelinating diseases with high-unmet need better such as MS and ALS. We are excited to add this highly relevant method to our portfolio of granted patents, Claudia Mattern, PhD, chief scientific officer at MetP Pharma, saidin apress release.

MetP Pharma noted it is pursuing otherpatent applications in all major markets worldwide.

Marisa holds an MS in Cellular and Molecular Pathology from theUniversity of Pittsburgh, where she studied novel genetic drivers ofovarian cancer. She specializes in cancer biology, immunology, andgenetics. Marisa began working with BioNews in 2018, and haswritten about science and health for SelfHacked and the GeneticsSociety of America. She also writes/composes musicals and coachesthe University of Pittsburgh fencing club.

Total Posts: 1,053

Patrcia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

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MetP Pharma Awarded US Patent for Potential Remyelination Therapy - Multiple Sclerosis News Today

the global Testosterone Replacement Therapy market. It also includes discussion on historical trends, current market status, competitive landscape, growth opportunities and challenges which are backed by factful feedbacks. The report extensively provides quantitative analysis of the industry from 2014-2026,by Region, Type, Application. Consumption assessment by application, production by type in different regions. Furthermore, the report quantifies the market share held by the major players of the industry and provides an in-depth view of the competitive landscape. The market size in terms of revenue (USD) and production is calculated for the study period along with the details of the factors affecting the market growth (drivers and restraints). The worldwide market for Testosterone Replacement Therapymarket will reach xxx Million USD in 2020 and is expected to grow at a CAGR of xx% 2021-2026.

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Geographically, global Testosterone Replacement Therapy market competition by top manufacturers, with production, price, revenue (value) and market share for each manufacturer; the top players includingAbbVieEndo InternationalEli lillyPfizerActavis (Allergan)BayerNovartisTevaMylanUpsher-SmithFerring PharmaceuticalsKyowa KirinAcerus Pharmaceuticals

On the basis of product, we research the production, revenue, price, market share and growth rate, primarily split intoGelsInjectionsPatchesOther

For the end users/applications, this report focuses on the status and outlook for major applications/end users, consumption (sales), market share and growth rate of Testosterone Replacement Therapy for each application, includingHospitalsClinicsOthers

Production, consumption, revenue, market share and growth rate are the key targets for Testosterone Replacement Therapy from 2014 to 2026 (forecast) in these regionsChinaUSAEuropeJapanKoreaIndiaSoutheast AsiaSouth America

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Who we areResearch Tradeshas a team of experts who is working on a comprehensive analysis of market research. This estimate is based on a comprehensive study of the future and estimates of future estimates, which can be used by various organizations for growth purposes.We distribute customized reports that focus on meeting the customers specific requirement. Our company provides a large collection of high-quality reports obtained by customer-centered approaches, thus providing valuable research insights.Contact Us:Email: [emailprotected]Call us: +1 6269994607 (USA), +91 7507349866 (IND)Web:www.researchtrades.comSkype ID: researchtradescon

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Global Testosterone Replacement Therapy Market Research Report 2020 By Manufacturers, Regions, Types And Applications - Bulletin Line

Dec. 9 protest.

Portland, Ore.

A protest erupted at Nikes international headquarters here on Dec. 9 when over 400 workers demanded better treatment for women by male supervisors and a name change to the newly renovated Alberto Salazar building.

Salazar, head coach for the prestigious Nike Oregon Project, trains Olympic-bound runners. In September, Salazar was banned from coaching for four years for illegally doping and trafficking testosterone. In October, the Nike project was shut down. Nike CEO Mark Parker had been in close communication with Salazar to see if topical testosterone would trigger a positive drug test.

Former Nike athlete Mary Cain, once called the fastest girl in the world, says Salazar was banned because of the doping scandal, but that he should have been banned because of his treatment of women.

In 2018 women in the company led an internal uprising over repeated harassment by male supervisors who made vulgar, degrading comments to women workers. Former Project members, including Cain and Amanda Begley, have now come forward to expose the toxic culture created by the all-male coaching team.

In 2013, 16-year-old Cain was signed by Nike and began training with Salazar. I joined Nike because I wanted to become the best female athlete ever, said Cain in a 2019 New York Times Op-ed video series about women athletes. Instead I was emotionally and physically abused in a system designed by Alberto and endorsed by Nike. Cain was ordered to take birth control pills and diuretics to keep her weight to 114 pounds: They were convinced that in order to get better I had to get thinner.

Elite women athletes and dancers who reduce their body fat below 22 percent run the risk of compromising their health, with problems such as amenorrhea (abnormal loss of a menstrual cycle) and RED-S syndrome energy depletion that affects metabolic rate, bone health, immunity, protein synthesis and cardiovascular health.

Cain experienced amenorrhea and broke bones during her Nike training. Tests on Begley revealed her body fat was only 11 to 12 percent. Cain and Begley said Salazar weighed them publicly and shamed them as being too fat if they gained weight.

In 2015, Cain began having suicidal thoughts and started cutting herself. Salazar and the staff psychologist, who was not certified, ignored her when she spoke of the problems. Cain then decided to quit the team and stop trying to make the Olympics.

Dream crazy

When Alysia Montao, one of the top three female runners in the world, announced she was going to have a baby, Nike paused her contract and stopped paying her health insurance. This was in addition to her losing her sponsors during that time.

Getting pregnant is the kiss of death for a female athlete, said Phoebe Wright, a runner sponsored by Nike from 2010 through 2016.

Nike company flyers distributed at the Dec. 9 protest warned Nike workers they would be fired if they spoke to the media. It is typical policy for sponsors to make athletes sign confidentiality clauses to prevent them from fighting for change.

Other company flyers at the protest thanked the protesters for walking with Nike to celebrate what women bring to sports and to champion equality. Flyers also claimed that company management was committed to face-to-face time with workers to share ideas.

Nike tells us to dream crazy; we say how about you stop treating our pregnancies like injuries, said Montao. Then they tell us to believe in something; we say how about maternity leave? How about when you tell my daughter she can achieve anything, you back it up.

(Photo credit: Wesley LaPointe)

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Nike: Do the right thing - Workers World

Selenium has been associated with positive health outcomes. Heres what you need to know.

Selenium is a mineral that appears naturally in soil, water, and some foods. Ongoing research has suggested that it can have positive effects on your health as it boosts immunity and staves off cancer, cardiovascular disease, thyroid problems, cognitive decline, infertility, and asthma. If its new to you, or youre just looking for more information, here are some things you should know.

Whether you get it through a supplement or by eating certain foods that well identify below, here are the recommended daily dietary allowances for selenium:

An overdose from consuming selenium in food is unlikely but one is more possible when taking selenium in supplements.

You can consume selenium via supplement, but can also find it in the following foods:

Studies published in the British Journal of Urology, Biological Trace Element Research, and Journal of Veterinary Research indicate that taking selenium supplements may increase testosterone levels and enhance male fertility.

Specifically, one 26-week study involving 468 men with infertility who took 200 mcg of selenium together with N-acetyl-cysteine daily showed increased testosterone production, sperm count, and sperm quality. In addition, asecond study involving 690 men with infertility who took 200 mcg of selenium together with 400 units of Vitamin E showed improved sperm motility and appearance in 53% of participants after just 100 days. Eleven percent of the men in that study got their partners pregnant.

Brazil nuts have also been linked with boosted testosterone levels as a result their high levels of naturally occurring selenium. Just one 28-gram serving of Brazil nuts provide 988% of the daily recommended dietary allowance of selenium.

Brazil nuts offer all kinds of positive health effects: boosts to antioxidants; support of thyroid function; theyre high in heart-healthy polyunsaturated fats; they have protective effects on the brain and mood-elevating properties; they may decrease blood sugar levels and improve insulin sensitivity; and reduced inflammation.

Researchers at Virginia Polytechnic Institute and State University, Virginia-Maryland College of Veterinary Medicine, University of South Dakota, and Texas A&M Univesity have experimented with supplementing the diets of farmed Nile tilapia with organic and non-organic selenium.

As it turns out, supplementing the fishs diet with organic selenium helps maintain their health. It also produced fish with higher concentrations of the beneficial mineral to be consumed by people. Its a potential win-win and a big deal, since aquaculture has shown the capacity to help respond to worldwide malnutrition.

Ongoing research has suggested that selenium can have positive effects on or help prevent immune health, cancer, cardiovascular disease, thyroid problems, cognitive decline, infertility, and asthma.

If you stay within those recommended daily dietary allowances, you should experience no negative side effects from selenium consumption. Going beyond recommended doses, however can be a problem. These are some signs of selenium toxicity:

Selenium can interact with other medicines and supplements, so you should always keep in mind what else youre consuming to avoid any negative complications. Things that Selenium can interact with include antacids, chemotherapy drugs, corticosteroids, niacin, statins to lower cholesterol, and birth control pills.

There have been studies indicating a relationship between Selenium supplements and an increased risk of squamous cell carcinoma (skin cancer). If youre already at high risk of developing skin cancer, avoid taking Selenium supplements.

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Have you caught onto the benefits of selenium? - Science 101

Annet Negesa had just finished training in Kampala, Uganda, in June 2012 when she received a call from a doctor from track and fields world governing body. He told her that she would no longer be competing in the London Olympics because her testosterone levels were too high for competition.

I went back into the house and started crying, she recalled.

Negesa was 20 at the time and one of the top athletes in her country, a promising middle-distance runner who had set a national record for 800 meters earlier in the year at a meet in Hengelo, the Netherlands. She was a three-time national champion and took home a gold medal at the 2011 All-Africa Games. The Uganda Athletics Federation named her athlete of the year.

World Athletics, formerly the International Association of Athletics Federations, or I.A.A.F., track and fields world governing body, did not catch Negesa using performance-enhancing drugs. Rather, she is an intersex athlete.

She identifies as female and was born with external female genitalia but also with internal male genitalia that produce levels of testosterone that men do. According to sports officials, that gave her an unfair advantage over most women in some events.

What makes Negesa different from so many other intersex athletes is that she tried to alter her body with surgery so she could continue to compete. Negesa claims that a doctor for World Athletics recommended the surgery. The federation denies this.

For seven years, Negesa, 27, refused to speak about what happened. But time did little to assuage her grievances.

Now I see my body as different, very, very different, she said. I dont know how to talk about it.

The years since the surgery have been a struggle. Negesa has battled persistent headaches and achy joints. Her postoperative care, she said, has not included the kind of hormone treatment that might have helped her body adjust to the change.

What happened to Annet is dangerous, and happened because she wanted to compete, said Payoshni Mitra, a researcher and activist on gender and sports who has lectured on the topic of intersex athletes.

For the past decade, Mitra has stood alongside numerous athletes with naturally high testosterone levels, including Caster Semenya, the South African middle-distance champion, and Dutee Chand, the Indian sprinter. Negesas case, however, was one of the most difficult ones for Mitra to reconcile because Negesa opted to have surgery.

For years, World Athletics has struggled to create rules that maintain a level playing field for the overwhelming majority of women with only female genitalia without impinging on the human rights of intersex people, who account for roughly one in every 2,000 births. A study this year found that female athletes with male testosterone levels are overrepresented in womens middle-distance races.

World Athletics, in a decade of research, found that nearly seven in every 1,000 elite female athletes are intersex athletes with levels of testosterone within the male range. Some endocrinologists have concluded it remains unclear whether high testosterone gives athletes a competitive edge, but many scientists believe it does.

After years of litigation, the Court of Arbitration for Sport in May upheld World Athletics testosterone restrictions for female athletes in races with distances from 400 meters to the mile. The court ruled by a 2-to-1 vote that the restrictions were indeed discriminatory but also a necessary, reasonable and proportionate means of achieving the World Athletics goal of preserving a level playing field in womens track events.

Most women, including elite female athletes, have natural testosterone levels of 0.12 to 1.79 nanomoles per liter, World Athletics said, while the typical male range after puberty is much higher, at 7.7 to 29.4 nanomoles per liter.

Intersex athletes who want to participate in middle-distance womens track events must take hormone-suppressing drugs and reduce testosterone levels below five nanomoles per liter for six months before competing, then maintain those lowered levels.

But Negesa, the eldest of nine siblings raised in a village in Jinja, Uganda, southeast of the Nile, had a much more invasive intervention after she learned in 2012 that she could not compete.

She said a World Athletics physician, Dr. Stphane Bermon, told her she needed to undergo medical treatment and was given surgery as her first option: a gonadectomy to remove her internal testes.

I love my sport so much, thats why I decided to go for the surgery, she said in a recent video interview from Germany, where she now lives.

After Negesa appeared in a documentary on German televisions ARD network in October, World Athletics issued a statement denying that it participated in or recommended a specific treatment to Negesa.

Dr. Bermon has never met the athlete in question and was not at either the consultation in Nice nor the surgery she speaks of in Uganda, the statement said. Through a World Athletics spokesman, Dr. Bermon declined to comment.

Negesa said she traveled alone to Nice for medical tests soon after learning she could not compete. She recalled having her body measurements taken by two doctors who spoke in French. Negesa speaks Swahili and English.

It was so weird, she recalled. I was shy.

She returned to Kampala for treatment, and paid $900 for the procedure.

On the morning of her surgery in Kampala, she had little knowledge of what she was about to undergo. Doctors had told her that it was a simple surgery and that she would return to competition in a few weeks.

I woke up in the morning feeling cuts on my body, she said. I felt so scared. I didnt know that I was going to be cut open.

She hasnt returned to the sport and has suffered from depression and joint pain since the operation.

Negesas medical record from the Womens Hospital International & Fertility Centre in Kampala was reviewed by The New York Times and confirmed that World Athletics, then known as the I.A.A.F., recommended a thorough medical examination, citing the high levels of testosterone in her body. The report states that after her testing in Nice she had a gonadectomy in Kampala. The document states that her surgeon in Kampala, Dr. Edward Tamale Sali, did not start her on hormone therapy because he was awaiting further discussion with Dr. Bermon.

Dr. Tamale Sali declined to comment.

In 2013, Dr. Bermon, now director of the World Athletics health and science department, published a report citing four unidentified athletes from developing countries who were referred to hospitals in France for naturally high testosterone levels.

I think I was the first one, Negesa said of the four athletes cited in the study. She said Dr. Bermon was the World Athletics official who first called her in 2012.

After Negesas appearance in the German documentary in September, 25 French athletes wrote to World Athletics, the International Olympic Committee and the minister of sports and health calling for an investigation.

The French minister of sports and minister of health opened a joint investigation in October.

In its statement, World Athletics said it does not advise athletes on preferred treatments and did not do so in this case. The global federation has never forced any athlete affected by its regulations to undergo surgery, nor paid for any of their treatment.

In March, the United Nations Human Rights Council condemned World Athletics attempt to regulate female athletes testosterone levels. And in May the World Medical Association advised physicians around the world to abstain from implementing the new regulations.

They are assigned female at birth and have grown up to have a female gender identity, so theres no question that they belong in that category, said Katrina Karkazis, a fellow at Yale Universitys Global Health Justice Partnership.

Negesa said that returning home, where L.G.B.T. individuals are openly condemned, would lead to imprisonment or death.

She filed for asylum in Berlin in September, and was granted it this month.

She runs every day, with the hope of one day returning to international competition. Her next step, though, is litigation. I need to take them to court, she said of World Athletics, for violating my human rights.

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This Intersex Runner Had Surgery to Compete. It Has Not Gone Well. - The New York Times

The market intelligence report on the Testosterone Replacement Therapy market forecasts its growth during the years 2019 to 2022. It examines the market size, share, demand, trends, gross revenue, total earnings and net value after a historical analysis of the data collected from the years 2019 to 2022 while taking 2018 as the base year. The study focuses on the driving factors, restrains and hurdles for the growth of the market. The researcher gives market insights relating to the upcoming areas in the business and the impact of technological innovations on the growth of the market.

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The size of the Testosterone Replacement Therapy market is viewed in terms of the Share of Market, Total Available Market as well as Served Available Market. Not only does the study present the combined revenue for a particular market but also the market size for a specific geographic region. Analysis of percentage or the size of the Total Available Market based on the type of product, technology, regional constraints and others form an important part of the Testosterone Replacement Therapy market report.

Scope of the Report:

This industry assessment for the forecast period, 2019 2022 incorporates projections pertaining to the investment feasibility, gross margin, profits, consumption volume, production capability and major market vendors. Likewise, statistics associated with the competitive landscape, shifting consumer behaviour and spending power is showcased and well-explained with the help of treasured resources such as charts, graphs and graphic images, which can be easily incorporated in the business or corporate presentations.

Segments covered in the report:

In market segmentation by manufacturers, the report covers the following companies

In market segmentation by geographical regions, the report has analysed the following regions

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In market segmentation by types of testosterone replacement therapies, the report covers

In market segmentation by applications of the testosterone replacement therapy, the report covers the following uses

Apart from this, the study assesses the weaknesses and strengths of the major market players operating across different regions. Analysis of prominent trends from past and future that is actively contributing to the growth of the Testosterone Replacement Therapy industry further plays an eminent role in helping business owners plan effective business strategies. Evaluation of various aspects such as import and export status, distribution channel, supply chain management, profit and gross margin is explained extensively in the report.

The research provides answers to the following key questions:

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Testosterone Replacement Therapy Market CAGR Growth Expected to Be Linear Says AbbVie, Endo International, Eli lilly - Alpha News Report

By Jonny Lupsha, News Writer

Geneticists at the University of California San Diego have developed a newer method of determining the human-equivalent age of mans best friend, Science reported. According to the article, its based on a relatively new concept in aging research: that chemical modifications to a persons DNA over a lifetime create what is known as an epigenetic clock. Based on this idea, scientists have built a promising model that adding methyl groups to certain parts of our DNA can determine our biological age, which it describes as the toll that disease, poor lifestyle, and genetics take on our bodies. The first step led to creating a more specific formula for determining canine lifespans than the old adage of multiplying by seven, but humans arent too far behind. So what else can our genes tell us about the future?

Some of our traits are influenced by our genes, and we know that our genetic makeup comes from our parents. One of the most famous manifestations of genetics passed down from our parents is the idea of the family resemblance. The reason why doctors ask us if any illnesses run in the family is because that can influence your likelihood to get a specific disease. If they do, the odds are more likely that an inherited predisposition to that disease could shorten your lifespan. So what can twins tell usnot fraternal twins, who are two siblings born at the same time, but identical twins, who share so many genetic similarities that theyre built almost identically?

In particular, if our genes really do influence our lifespan, then we would expect the lifespans of identical twins to be more similar than the life spans of fraternal twins, said Dr. Thad Polk, an Arthur F. Thurnau Professor in the Department of Psychology and the Department of Electrical Engineering and Computer Science at the University of Michigan. It turns out they are.

Dr. James Vaupel and some of his colleagues in Denmark and Minnesota analyzed the lifespans of 2,872 Danish twin pairs who were born between the years 1870 and 1900, Dr. Polk said. Sure enough, they found that the correlation between age at death was higher in the identical twins than it was in the fraternal twins. Based on their data, they estimated that about 25 percent of the variability in lifespan could be attributed to genetic factors.

Dr. Polk said that British biologist Sir Peter Medawar proposed a theory in 1952 about why we die at all. Calling it the mutation accumulation theory of aging, Sir Peter proposed that natural selection has less and less of an effect as we get older. Why would this occur?

Two reasons: First, given that nature is dangerous and individual animals are getting killed off all the time, there simply wont be that many old animals around, Dr. Polk said. So if a genetic variant exists that causes old animals to become frail and die, it wont make much difference, because the animal isnt likely to reach that age anyway.

The second reason is that genetic variants that have harmful effects late in life will have already been passed on to offspring, Dr. Polk said. Sir Peter Medawar used to use Huntingtons disease as an example of this, which Dr. Polk illustrated. The age of onset for Huntingtons disease is typically after age 35, and so many patients have already passed on the mutant gene to their offspring before they even knew that they have the disease.

The mutation accumulation theory is no longer universally accepted, but it is the foundation for another popular theory that may provide answers in the future, called antagonistic pleiotropy.

According to Dr. Polk, pleiotropy describes how one gene can have different effects within a single organism. George Williams at Michigan State University proposed that sometimes these effects could be antagonisticone effect of the gene might be beneficial to the organism while another effect is harmful. Finally, Williams said this may account for age-related genetic effects.

In a much simpler example, high testosterone levels in men fit Williamss hypothesis. Genetic variants that produce higher testosterone levels tend to increase fertility and reproductive success, but higher testosterone levels also increase the risk of developing prostate cancer later in life, Dr. Polk said. Nevertheless, from the viewpoint of natural selection, the benefit of improved reproductive success early in life outweighs the cost of increased cancer risk later in life, and so high testosterone levels continue to be selected for.

While natural deaths are still sometimes muddied with riddles, the given proof of how genetics influence our lifespans lends credence to theories like antagonistic pleiotropy and the epigenetic clock. Studying methyl levels in DNA promises to yield insightful results in coming years.

Dr. Thad A. Polk contributed to this article. Dr. Polk is an Arthur F. Thurnau Professor in the Department of Psychology and the Department of Electrical Engineering and Computer Science at the University of Michigan. He received a B.A. in Mathematics from the University of Virginia and an interdisciplinary Ph.D. in Computer Science and Psychology from Carnegie Mellon University.

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New Way to Calculate "Dog Years" Raises Questions of Aging and DNA - The Great Courses Daily News

Men are nearly two times more likely to develop blood clots while undergoing testosterone therapy, according to University of Minnesota research.

The study, which was published last month, found that men on testosterone therapy were at a heightened risk of developing a condition commonly known as VTE. With this condition, blood clots form in the veins and travel to the lungs, potentially blocking the blood supply. Men seek testosterone therapy for a variety of reasons, including low testosterone levels and sexual dysfunction.

These findings were shown in both men with and without hypogonadism, a condition where the body does not produce enough testosterone naturally.

There hasnt really been [this] kind of care given to a hypogonadism diagnosis. A lot of other studies either control for it or restrict it to one specific group of men, said Robert Walker, the study's lead and a research assistant at the Universitys Minnesota Population Center.

In the study, researchers separated men with the condition and men without it. By doing so, they were able to see a near doubling of risk in both groups, he said. They were also able to control for factors such as smoking status, obesity and race.

Overall for Americans, there [are] about 1 million cases of VTE annually, Walker said, which includes a lifetime risk of one in 12 people. Symptoms include leg pain, swelling and rashes.

While men typically receive testosterone therapy for hypogonadism, they may also seek it for unwanted weight gain or emotional regulation.

"These findings are important, particularly for the men with no hypogonadism, as they suggest that off-label testosterone use for symptoms of 'male menopause' may be causing harm, said Pamela Lutsey, a co-author of the study and University associate professor in the Division of Epidemiology and Community Health, in an email to the Minnesota Daily.

When men seek testosterone therapy for reasons other than hypogonadism, there is not necessarily an official diagnosis. However, treatment could fix those symptoms, Walker said.

Testosterone therapy is more than just a kind of stroke and heart failure risk factor, we have to take into account other cardiovascular symptoms, he said.

In the future, the researchers can use the same study design to test the effects of testosterone therapy on women, Walker said.

Women who need to take testosterone for one reason or another may also be put at a risk, he said.

Women are often at risk of developing VTE while pregnant because of the pressure on their organs or afterward in the postpartum period, Walker said.

An important next step is for other researchers to reproduce these results, said Richard MacLehose, another co-author of the study and University associate professor in the Division of Epidemiology and Community Health.

Walker said he began this study because of the lack of research papers on the effects of testosterone therapy.

The story of the paper is really just to think before you prescribe, he said.

Continued here:
Men who receive testosterone therapy nearly twice as likely to develop blood clots, researchers find - Minnesota Daily

NORTHBROOK, Ill., Dec. 11, 2019 (GLOBE NEWSWIRE) -- Clarus Therapeutics, Inc. today announced the appointment of five senior leaders, each of whom bring valuable industry and category experience to the team. Together they strengthen the companys commercialization capability for JATENZO (testosterone undecanoate) capsules, the first-in-class oral testosterone replacement therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypogonadism. See indication and important risk information, including boxed warning below.

Dr. Newmark, Mr. Jaeger, Mr. Rodriguez, Ms. Wright and Mr. Holloway join a management team led by Robert Dudley, Ph.D., Clarus Therapeutics Chief Executive Officer and co-inventor of JATENZO. Dr. Dudleys legacy in mens health includes CEO leadership of the company that developed and launched AndroGel, a product he co-invented and the last major advancement in testosterone replacement therapy delivery.

We are proud to bring Jay, Frank, Jose, LaTonya, and James into an organization that shares their focus on innovation and excellence. They have each demonstrated an ability to connect with medical professionals who are invested in mens health, said Dudley. Their expertise will help us make the long sought-after oral testosterone option widely available to appropriate hypogonadal men.

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 carcinoma of the breast or known or suspected carcinoma of the prostate, in women who are pregnant, in men with a known hypersensitivity to JATENZO or its ingredients, or in men with hypogonadal conditions that are not associated with structural or genetic etiologies as JATENZO has not been established for these conditions and there is a risk of increased blood pressure with JATENZO that can increase the risk of MACE.

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%).

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

The safety and efficacy of JATENZO in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.

There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing JATENZO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. There is insufficient long-term safety data in geriatric patients utilizing JATENZO to assess the potentially increased risk of cardiovascular disease and prostate cancer.

Please see accompanying full Prescribing Information, including BOXED WARNING on increases in blood pressure.About JATENZO JATENZO is a first-in-class proprietary oral soft gel formulation of testosterone undecanoate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

JATENZOs proprietary formulation is built around testosterone undecanoate a testosterone prodrug that the body converts to testosterone. In the JATENZO pivotal inTUne (investigation of its oralTestosteroneUndecanoate) clinical trial, 87% (n=222) of men treated with JATENZO achieved average circulating levels of testosterone in the normal range for men.

About Clarus Therapeutics, Inc.Clarus is a men's specialty pharmaceutical company developing and preparing for the commercial launch of JATENZO, a product protected by patents issued in the United States and in other major pharmaceutical markets around the world. Clarus owns the worldwide, royalty-free commercialization rights for JATENZO.For more information, please visit:www.clarustherapeutics.com.

Media ContactAmir KhanPhone: (212) 462-8767Email: Amir.Khan@Syneoshealth.com

2019 Clarus Therapeutics, Inc. All rights reserved.

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Clarus Therapeutics Expands Executive Team in Preparation for Landmark Launch of JATENZO (testosterone undecanoate) Capsules CIII - GlobeNewswire

A 36-year-old cis man born without testicles in Belgrade, Serbia has just received a testicular transplant from his identical twin brother to help his body produce its own testosterone and sperm.

Its only the third such surgery ever to occur in the world, and doctors say it could eventually be applied to trans men using the removed testicles of trans women, but ethical and legal concerns could complicate the matter.

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The surgery was a success, though it wasnt easy. It involved sewing together two arteries and two veins that were less than 2 millimeters wide within two to four hours before the organ became non-viable, according to The New York Times. Both brothers are doing well, they both now have one testicle each and the recipients testosterone levels are already at normal levels.

Because the men both have the same genetic makeup, theres no need for the immune-suppressing drugs that most transplant recipients require to avoid having their bodies reject foreign tissue.

The brothers contacted lead surgeon Dr. Miroslav Djordjevic about the procedure after theyd heard hed performed a successful uterus transplant between twins sisters, enabling the recipient to give birth. In the testicular procedure, Dr. Djordjevic didnt reconnect the testicles vas deferens, which wouldve enabled the recipient to release sperm from the donated testicle. Such a reconnection is possible.

Though its rare for a cisgender man to be born without testicles, Dr. Djordjevic says the testicular transplant could also be applied to accident victims, wounded soldiers, cancer patients and trans men using testicles donated by transgender women and others.

However, a legal issue might arise as anyone who fathered children using sperm released or harvested from a donated testicle as the child would, in essence, have the donors DNA and not the recipients the donor or their surviving loved ones would likely have to give permission to have children in such a case, raising a potentially sticky legal issue.

Several transgender men have contacted Dr. Djordjevic to ask if the surgery could help them develop testosterone without the need for constant hormone injections. While Djordjevic says the potential rejection of donor tissue remains the largest consideration for whether or not to attempt any organ transplants, he also says he has developed a surgical plan for transplanting a penis onto a body that is anatomically female, and that he hoped to begin performing that surgery within the next year or so, according to The New York Times.

The rest is here:
Surgeons successfully performed a testicle transplant. The procedure could help trans men one day. - LGBTQ Nation

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