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Long-term testosterone therapy appears to improve erectile function and reduce mortality in men with hypogonadism and type 2 diabetes mellitus, according to a recent study presented at the 2021 Sexual Medicine Society of North America Fall Scientific Meeting.1

A total 361 men with hypogonadism (defined as total testosterone 350 ng/mL and at least moderate symptoms as assessed by the Aging Males Symptoms scale) in a single urology office had type 2 diabetes mellitus. Of these men, 183 received testosterone undecanoate injections of 1000 mg/12 weeks following an initial 6-week interval, with 178 patients opting to not receive TU injections serving as controls. International Index of Erectile Function-Erectile Function (IIEF-EF) domain score was assessed at each visit. Mortality was recorded based on reports from the patients general practitioners.

Changes over time between groups were compared by a mixed effects model for repeated measures with a random effect for intercept and fixed effects for time, group and their interaction and adjusted for age, weight, waist circumference, blood pressure, fasting glucose, lipids and quality of life to account for baseline differences between groups, wrote the authors, led by Farid Saad, MD, of Bayer AG and Gulf Medical University School of Medicine, Ajman, United Arab Emirates.

Mean follow-up was 8.23.2 years (median, 8 years) in the treatment group and 9.22.8 years (median, 10 years) in the control group. Total observation time was 1508 years in the treatment group vs 1641 years in the control group. Age at baseline was 60.75.5 years in the treatment group and 63.04.9 years for the controls (P < .0001). Phosphodiesterase 5 inhibitor usage at baseline was 27.3% in the treatment group vs 34.3% of the control group (P = .1527). At first visit, erectile dysfunction (ED) was reported by 64.5% of the treatment group vs 54.5% in the control group. In patients who did not report ED, the condition was diagnosed using the IIEF-EF in 30.6% of patients in the treatment group vs 44.4% in the control group, and 4.9% of patients in the treatment group and 1.1% in the control group had no ED.

Regarding erectile function, in year 12 for the treatment group, IIEF-EF increased by 12.10.4 (least squares means standard errors), whereas IIEF-EF decreased by 14.20.4 in the control group. Estimated adjusted difference between the 2 groups was 26.3.

Over the observation period, 15 patients (8.2%) in the treatment group died compared with 61 patients (34.3%) in the control group (P < .0001).

Our mortality data confirm the results by Hackett et al2,who observed the lowest mortality in a subgroup of men receiving continuous long-term [testosterone therapy], the investigators concluded.

References

1. Saad F, Haider A, Haider KS, Doros G, Traish A. Long-term testosterone therapy improves erectile function and reduces mortality in men with hypogonadism and type 2 diabetes updated results from a registry study. Paper presented at 2021 Sexual Medicine Society of North America Fall Scientific Meeting; October 21-24, 2021; Scottsdale, Arizona. Abstract 001

2. Hackett G, Cole N, Mulay A, Strange RC, Ramachandran S. Long-term testosterone therapy in type 2 diabetes is associated with reduced mortality without improvement in conventional cardiovascular risk factors. BJU Int. 2019;123(3):519-529. doi:10.1111/bju.14536

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Long-term testosterone improves erectile function, reduces mortality in men with hypogonadism and diabetes - Urology Times

JATENZO (testosterone undecanoate) is the first and only FDA-approved oral softgel for testosterone replacement therapy (TRT) in adult males who have deficient testosterone due to certain medical conditions

Upon issuance, Clarus plans to list these patents in FDAs Orange Book, which would bring the total number of Orange Book-listed patents covering JATENZO (testosterone undecanoate) to seven

NORTHBROOK, Ill., Oct. 26, 2021 (GLOBE NEWSWIRE) -- Clarus Therapeutics Holdings, Inc. (Clarus) (Nasdaq:CRXT), a pharmaceutical company dedicated to providing solutions to unmet medical needs by advancing androgen and metabolic therapies for men and women, today announcedthat it has received two notices of allowance from the United States Patent and Trademark Office (USPTO) for claims that cover its oral testosterone replacement product, JATENZO (testosterone undecanoate).

Patent application No. 16/656,157 entitled Oral Testosterone Ester Formulations and Methods of Treating Testosterone Deficiency Comprising Same and patent application No. 15/814,162 entitled Pharmaceutical Delivery Systems for Hydrophobic Drugs and Compositions Comprising Same both cover Clarus approved product JATENZO (testosterone undecanoate). The U.S. patents scheduled to issue from these applications will expire in 2030 and 2026, respectively.

These recent patent allowances by the USPTO are another important milestone in protecting the commercial potential of JATENZO and the life cycle management programs we have under development for this lead asset, said Dr. Robert Dudley, Founder, President and Chief Executive Officer of Clarus. Once issued, these two new patents will be listed in FDAs Orange Book and will bring the total number of patents that protect JATENZO to seven. These new patents will further strengthen the broad and robust intellectual property portfolio for JATENZO.

About Male Hypogonadism Male hypogonadism is a condition that results when the testes do not produce enough testosterone. Symptoms associated with male hypogonadism can include depression, decreased sex drive, decreased muscle mass, and decreased bone density, among others. An estimated 20 million men in the U.S. have hypogonadism, with approximately 6 million patients diagnosed. Treatments for male hypogonadism may include testosterone replacement therapy (TRT).

About Clarus Therapeutics Holdings, Inc.Clarus Therapeutics Holdings, Inc. is a pharmaceutical company with expertise in developing androgen and metabolic therapies for men and women including potential therapies for orphan indications. Clarus Therapeutics first commercial product is JATENZO. For more information, visit http://www.clarustherapeutics.comand http://www.jatenzo.com. Follow us on Twitter (@Clarus_Thera) and LinkedIn (Clarus Therapeutics).

Clarus Forward-Looking StatementsCertain statements in this press release constitute forward-looking statements for purposes of the federal securities laws. The words anticipate, believe, contemplate, continue, could, estimate, expect, intends, may, might, plan, possible, potential, predict, project, should, will, would and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Clarus forward-looking statements in this press release include, but are not limited to, statements regarding the issuance of these patents, listing in the FDAs Orange Book and the effect of these patents on the JATENZO patent portfolio. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that Clarus has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Clarus control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks associated with pharmaceutical development, risks associated with Clarus financial position, and those factors described under the heading Risk Factors in the prospectus filed with the Securities and Exchange Commission (the SEC) under Rule 424(b)(3) on October7, 2021, and those that are included in any of Clarus future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of Clarus assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by the COVID-19 pandemic and there may be additional risks that Clarus considers immaterial, or which are unknown. It is not possible to predict or identify all such risks. Clarus forward-looking statements only speak as of the date they are made, and Clarus does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Clarus Investor Relations Contact:Kara Stancellkstancell@clarustherapeutics.com(847) 562-4300 x 206

About JATENZO

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

IMPORTANT SAFETY INFORMATION

WARNING: INCREASES IN BLOOD PRESSURE

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

WARNINGS AND PRECAUTIONS

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

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

2021 Clarus Therapeutics, Inc. All rights reserved.

Link:
Clarus Therapeutics Announces Two Notices of Allowance for - GlobeNewswire

Spains former king Juan Carlos was allegedly injected with female hormones by Spanish secret service to control his rampant sex drive, an ex-police chief has sensationally claimed.

Jose Manuel Villarejo, an ex-police commissioner currently on trial over blackmail allegations, told a parliamentary hearing on Wednesday that Spains National Intelligence Centre (CNI) had to administer the 83-year-old exiled monarch female hormones and testosterone inhibitors to lower his libido.

Giving reasons for the extreme action, Villarejo said Carlos sex drive was considered as a problem for the state because he was such an ardently passionate person, Spanish media reported.

During the hearing, the former police chief said he had been tasked to recover medical reports relating to scans that Juan Carlos had while he was undergoing treatment for a benign tumour.

Also read |Spain's former king Juan Carlos flees the country

He said, There were traces not of bromide (a sedative) but of testosterone inhibitors.

The revelations come after a Spanish author and military historian Amadeo Martinez Ingles wrote a book entitled Juan Carlos: The King Of 5,000 Lovers, detailing evidence of his sexual history and describing the king as a "rampant sex addict".

It has been speculated that the former king has had intimate relations with over 5,000 women, including Danish-German philanthropist Corinna Larsen, Spanish singer Sara Montiel, Belgian governess Liliane Sartiau and Italian princess Maria Gabriela de Saboya, besides his wife, Queen Sofia.

Also read |Spain's former king Juan Carlos has been in UAE since August 3

Villarejos trial opened this month, in which he is accused of having covertly recorded conversations with the elite for the purposes of blackmailing or ruining their reputation on behalf of other powerful clients.

He denied having any involvement in the effort to bring Juan Carlos notorious sex drive under control and said he found out about it from Corinna Larsen, a former lover of the ex-monarch now living in London.

The former king reigned from 1975 to 2014, but abdicated his throne for of his son. He fled Spain for Abu Dhabi, United Arab Emirates, last year amid a multi-million dollar corruption scandal.

(With inputs from agencies)

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Spains former king Juan Carlos injected with female hormones to control his sex drive: Ex-cop - WION

Testosterone Injectable Market study by Future Market Insights provides details about the market dynamics affecting the market, Covid-19 Impact, Market scope, Market segmentation and overlays shadow upon the leading market players highlighting the favorable competitive landscape and trends prevailing over the years.

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The report facilitates in determining and interpreting the key market players, portfolios with necessary information such as company profiles, components and services offered, financial information of past few years, key developments in past few years, that helps in constructing strategies to gain competitive advantage in the long run. The report also analyzes factors affecting Testosterone Injectable Market from both demand and supply side and further evaluates market dynamics effecting the market during the forecast period i.e., drivers, restraints, opportunities, and future trend.

Leading Testosterone Injectable Market Players:

Key Elements that the report acknowledges:

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Ground breaking research and market player-centric solutions for the upcoming decade according to the present market scenario

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Future Market Insights (FMI) is a leading provider of market intelligence and consulting services, serving clients in over 150 countries. FMI is headquartered in Dubai, the global financial capital, and has delivery centers in the U.S. and India. FMIs latest market research reports and industry analysis help businesses navigate challenges and make critical decisions with confidence and clarity amidst breakneck competition. Our customized and syndicated market research reports deliver actionable insights that drive sustainable growth. A team of expert-led analysts at FMI continuously tracks emerging trends and events in a broad range of industries to ensure that our clients prepare for the evolving needs of their consumers.

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Testosterone Injectable Market Trend 2021, Growth, Leading Companies with Impact of Covid-19, Business Scenario, Emerging Dynamics, Industry Share and...

Scientists are learning more and more about human biological variation, including of sex characteristics. But images of the human body in anatomy remain mostly muscular, white, and male with limited diversity, including of sex.

Intersex people represent just under 2% of the population a comparable percentage to people born with red hair. Yet anatomy textbooks used in Australian medical schools almost completely stick to the male-female sex binary. In our earlier research we found intersex was included in only five of 6,004 images across 17 texts. This marginalises intersex people, who have been persistently discriminated against within the health-care system.

The intersex community is the often forgotten I in LGBTQI+. Intersex Human Rights Australia highlights the need for increased visibility and to prevent unnecessary surgeries. Now there are fresh calls for health and medical students to learn about sex characteristics as a continuum rather than as male or female.

Read more: Marriage equality was momentous, but there is still much to do to progress LGBTI+ rights in Australia

Sex development in utero is complex, involving at least 70 different genes.

Our sex is defined by our genes (Y or X chromosome), gonads (ovaries or testes), reproductive tract, and external genitalia.

Whether a foetus develops female, intersex or male characteristics is determined by four key elements. These are the Y chromosome and its sex-determining gene (SRY gene), and two hormones (anti-Mullerian hormone and testosterone).

A foetus with all four elements will develop male sex characteristics.

At 67 weeks gestation, the SRY gene on the Y chromosome signals the gonads to develop into testes. About 23 weeks later, secretion of two hormones by the testes directs further sex development. Anti-Mullerian hormone stops female sex characteristic development. Testosterone stimulates development of the male reproductive tract and external genitalia.

When all four elements are absent, female sex characteristics develop.

Without a Y chromosome and its SRY gene, the gonads develop into ovaries. Without anti-Mullerian hormone or testosterone production, the female reproductive tract and external genitalia develop.

The presence of some but not all of these elements results in the development of intersex characteristics.

Intersex can include both or a combination of male and female sex characteristics, depending on variations in chromosomes, genes or hormones. This represents the continuum of the sex spectrum between the male and female binaries.

Known variations in the Y and X chromosomes include XY (genetic male), XXY (Klinefelter syndrome), X (Turner syndrome), XX (genetic female). Variations in the gonads include the presence of both ovaries and testes, or only partial development of either. Other intersex variations include a combination of male and female genitalia, and external genitalia that differs in sex to the genetic sex.

Intersex traits are not always visible at birth. Individuals may not realise they are intersex until puberty, or only if they undergo assessment for infertility or genetic testing.

There is a tragic history of irreversible surgical interventions in intersex infants and children. This was often without their consent, or with parents coerced to consent.

These surgeries have been to normalise external genitalia to a male or female binary. The impact of these procedures may violate human rights. They can be devastating for intersex peoples lifelong physical and mental well-being.

The UN Office of the High Commissioner for Human Rights description of intersex is having sex characteristics that do not fit typical binary notions of male or female bodies. But even this pathologises intersex by indicating that intersex people do not fit.

Normalisation of sex variation and increased visual representation of intersex in anatomy is necessary to reduce stigma.

The minimal visual representation of intersex people in anatomy textbooks can affect students attitudes towards this. We have previously found viewing gender-biased images of anatomy is associated with higher implicit gender bias. Todays students are our next generation of doctors and health-care workers.

Read more: What are gender pronouns and why is it important to use the right ones?

Teaching sex characteristics based on a male-female binary is inaccurate and outdated. Weve also shown it negatively influences the healthcare of intersex individuals.

Both the University of Wollongong and the University of New South Wales are developing inclusive anatomy curricula within their medicine and health degrees. Harvard Medical School and University of British Columbia are also developing online, accessible resources to promote inclusive anatomical representation in medical education.

Inclusive teaching and knowledge of sex variation can be transformative beyond anatomy.

Teaching sex characteristics as a continuum will increase the visibility and understanding of intersex. Removing the stigma associated with sex (and other) variations in anatomy, and medical and health education is essential for optimal health, well-being, belonging and connection for everyone.

Read more from the original source:
Anatomy texts should show sex as a spectrum to include intersex people - The Conversation AU

Lipocine Inc. (NASDAQ: LPCN) and Antres Pharma Inc. have signed an exclusive licensing agreement for the commercialization of TLANDO in the US. TLANDO is a testosterone replacement therapy for treating adult males with conditions associated with endogenous testosterone deficiency or absence, such as hypogonadotropic hypogonadism or primary hypogonadism.

TLANDO received provisional approval from the US FDA, as previously disclosed. The drug will be eligible for final approval once the exclusivity term given to Clarus Therapeutics, Inc. under the Hatch-Waxman Act with respect to its medicine, JATENZO, expires on March 27, 2022. The agency has confirmed that the NDA resubmission for TLANDOs final approval will be classified as a Class 1 resubmission, with a goal period of two months for FDA review.

According to agreement terms, Lipocine will receive an $11 million payment upfront, an additional $5 million licensing payment by January 2025, and another licensing payment of $5 million by January 2026. Also, the company will be entitled to sales-based milestone payments of up to $160 million based on net sales of TLANDO. Liposcine will retain TLAND rights for all ex-US jurisdictions and for non-TRT indications. On the other hand, Antres Pharma will be responsible for commercial and post-marketing roles in the US.

Liipocine CEO and President Mahesh Patel said, We are very pleased to be partnering with Antares Pharma, a strong market leader with one of the largest sales forces in the TRT space. Our agreement with Antares Pharma demonstrates our commitment to ensure efficient and effective patient access to TLANDO in the U.S. We are confident in Antares Pharmas capabilities, given its established marketing experience and demonstrated success in the TRT space. Consistent with our current core competency, this agreement allows us to focus diligently on progressing our innovative pipeline candidates with the goal of serving patients with serious unmet need.

Read more from the original source:
Lipocine Inc. (NASDAQ: LPCN And Antres Pharma signs Exclusive Commercialization Agreement for TLANDO In The US - BP Journal

But the goal is never to eliminate stress. Youll only get more stressed if you try. Because guess what? The less stress you experience, the more stressful, less stressful things seem. Just as muscles grow with each workout, our bodies adapt to stressors and can deal with more of them.

But before you go out there and try to stress yourself out and bulk up your stress response, know this. How you respond to it impacts whether stress makes you stronger or weaker.

If you stress out, self-medicate and marinate in stress, it destroys your immune system and disrupts hormone production. But when you learn to manage it and let stuff go, your bodys ability to handle stress with a lesser stress response increases. So you need fewer stress hormones to deal with stress.

Vitamin D is, in fact, a hormone, not a vitamin. You produce it when exposed to sunlight. But you can also get it from mushrooms, eggs, supplements, and fortified products.

Vitamin D is critical for testosterone production, so you need to make sure youre getting enough of it to increase this vital hormone.

Read more:
7 Healthy And Natural Ways To Increase Testosterone - Longevity LIVE - Longevity LIVE

You may have seen ads targeting men with low testosterone or low T promising all kinds of benefits...but are they too good to be true?

Dr. Drew Oliveira, Senior Executive Medical Director for Regence BlueCross BlueShield says, The truth of it is, our testosterone gets lower as we age.

Oliveira says you may have heard that pills or supplements that can reverse this problem. And while there are some conditions that require testosterone replacement - contrary to advertisements, reduced vitality, strength and even demeanor or mood are not really a diagnostic for low testosterone.

Oliveira says to keep in mind that, Testosterone replacement has risks. A study of 15,000 older men men, showed a 21 percent increase in cardiovascular events in that group heart attacks, strokes. So, its not 100 percent safe to replace testosterone, especially in that population.

Instead, he suggests some other ways to stay healthy as you age.

First, if you smoke, stop smoking. Second, if you need to drink, limit your drinks to two drinks a day.

Alcohol use, Oliveira says, is associated with higher risks of cancer and cardiovascular risks, including hypertension.

Oliveira says you should also focus on diet and exercise to ensure healthy aging.

Maintain an ideal body weight. If youre overweight, even losing five percent will help. Eat healthy, what you eat should be very colorful, fruits, vegetables, grains, limit the amount of fats in your diet. All those things will help.

150 minutes of vigorous activity is also recommended each week.

If you do those things, you will feel better, you will feel younger, you will stay fit, you will live in optimum health, and you will live longer, says Oliveira.

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What men really need to know about low 'T' - fox13now.com

This article was originally published here

Medicine (Baltimore). 2021 Aug 27;100(34):e27072. doi: 10.1097/MD.0000000000027072.

ABSTRACT

In patients with coronavirus disease 2019 (COVID-19), men are more severely affected than women. Multiple studies suggest that androgens might play a role in this difference in disease severity. Our objective was to assess the association between sex hormone levels and mortality in patients with severe COVID-19.We selected patients from the Amsterdam University Medical Centers COVID-19 Biobank, in which patients admitted to hospital in March and April 2020, with reverse transcription-polymerase chain reaction proven severe acute respiratory syndrome-coronavirus-2 infection, were prospectively included. Specifically, we included postmenopausal women (>55 years) and age-matched men, with a mortality of 50% in each group. Residual plasma samples were used to measure testosterone, estradiol, sex hormone binding globulin (SHBG), and albumin. We investigated the association of the levels of these hormones with mortality in men and women.We included 16 women and 24 men in March and April 2020 of whom 7 (44%) and 13 (54%), respectively, died. Median age was 69 years (interquartile range [IQR] 64-75). In men, both total and free testosterone was significantly lower in deceased patients (median testosterone 0.8 nmol/L [IQR 0.4-1.9] in deceased patients vs 3.2 nmol/L [IQR 2.1-7.5] in survivors; P < .001, and median free testosterone 33.2 pmol/L [IQR 15.3-52.2] in deceased patients vs 90.3 pmol/L [IQR 49.1-209.7] in survivors; P = .002). SHBG levels were significantly lower in both men and women who died (18.5 nmol/L [IQR 11.3-24.3] in deceased patients vs 34.0 nmol/L [IQR 25.0-48.0] in survivors; P < .001). No difference in estradiol levels was found between deceased and surviving patients.Low SHBG levels were associated with mortality rate in patients with COVID-19, and low total and free testosterone levels were associated with mortality in men. The role of testosterone and SHBG and potential of hormone replacement therapy needs further exploration in COVID-19.

PMID:34449505 | DOI:10.1097/MD.0000000000027072

Read this article:
Sex steroid hormones are associated with mortality in COVID-19 patients: Level of sex hormones in severe COVID-19 - DocWire News

To achieve optimal health, balanced hormones are required, no matter whether you are a man or a woman. Many men experience symptoms of weight gain, decreased motivation, low libido, depression, and tiredness as they start to get older and their testosterone levels lower. This is known as Andropause, which is commonly deemed male menopause. Going through these symptoms can easily make you feel down and stressed.

There are options available, and one solution to consider is what is known as male hormone replacement therapy. Below, we will reveal everything you need to know about it to get a much better understanding of what it is and what it entails.

The main benefit of male hormone replacement therapy is that it will help to lower and even reverse the symptoms associated with getting older. A lot of people have reported feeling more vigorous and younger after going through the treatment phase. However, all of the symptoms mentioned can cause a person to feel down and depressed, so male hormone replacement therapy helps make sure you enjoy life again.

When it comes to male hormone replacement therapy, otherwise known as testosterone replacement therapy, the man will be given testosterone. This is the hormone responsible for producing male characteristics, such as muscularity and facial hair, as well as the development of the male sex organs.

It is important to talk with a specialist at a clinic to determine whether or not male hormone replacement therapy is right for you. This is why the consultation phase is imperative. It will give them a full understanding of the condition you are experiencing and your medical history. This will enable the professional to come to the best decision on what will be right for you.

There are many different ways that you can go about male hormone replacement therapy. While some of the different methods do include injections, some do not require them at all. We will be able to talk you through some of the different available options. Aside from injections, some of the other choices include patches and testosterone gels.

Because of the rise of the Internet, there is a lot of misinformation out there nowadays. Recent research indicates that there is no link between prostate cancer and male hormone replacement therapy. In a study that was carried out whereby 1,500 patients were observed, it was deemed that higher testosterone levels may even help lower the risk of prostate cancer. Moreover, the risk of prostate cancer may increase if you have low testosterone levels, and therefore, there is no link between this type of cancer and Male Hormone Replacement Therapy.

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Considering Male Hormone Replacement Therapy To Improve Health - Muncie Voice

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