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Shalender Bhasin, MBBS

Credit: UKMC

A substudy of the TRAVERSE trial revealed the progression from prediabetes to diabetes did not significantly differ between testosterone replacement therapy (TRT) or placebo treatment among middle-aged and older men with hypogonadism.1

The nested TRAVERSE Diabetes Study, an intention-to-treat analysis within the placebo-controlled randomized clinical trial, was conducted at 316 trial sites in the United States. Among the more than 5200 randomized participants, TRT did not improve glycemic control in those with hypogonadism and prediabetes or diabetes.

The findings of this study suggest that TRT alone should not be used as a therapeutic intervention to prevent or treat diabetes in men with hypogonadism, wrote the investigative team led by Shalender Bhasin, MBBS, Boston Claude D. Pepper Older Americans Independence Center, Brigham and Womens Hospital, Harvard Medical School.

Evidence has linked low testosterone to an increased risk of prediabetes and type 2 diabetes (T2D) in men.2 Men with prediabetes and diabetes have a high prevalence of hypogonadism, while a substantial portion of individuals receiving TRT have diabetes or prediabetes.3 TRT in men with hypogonadism can reduce whole-body and visceral fat mass, increase muscle mass, and improve insulin sensitivity.

As it is not well-understood, Bhasin and colleagues suggested further knowledge on testosterones efficacy in preventing progression from prediabetes to diabetes or in inducing glycemic control would be beneficial for clinicians, as well as patients weighing the benefit-risk profile of TRT.1

Men aged 45 to 80 years with hypogonadism and prediabetes, or diabetes were enrolled in TRAVERSE between May 2018 and January 2023. Participants were randomized 1:1 to receive 1.62% testosterone gel or placebo gel until the end of the study. All participants, the study staff, and those assessing outcomes were blinded to randomization.

The primary endpoint of the TRAVERSE Diabetes Study was the risk of progression from prediabetes to diabetes, assessed at all post-randomization time points using repeated-measures log-binomial regression. Secondary endpoints consisted of the risk of glycemic remission in those with diabetes at baseline, defined as a hemoglobin A1c level of 6.5% or two fasting glucose measurements <126 mg/dL without antidiabetic medication use.

Of the 5246 individuals randomized in TRAVERSE, 5204 were included in the analysis set for the nested substudy. Among this population, 1175 had prediabetes (607 randomized to TRT), and 3880 had diabetes (1917 randomized to TRT). Baseline characteristics were similar between the testosterone- and placebo-treated cohorts with prediabetes or diabetes the mean age was 63.8 years, and the mean HbA1c level was 5.8%.

Upon analysis, investigators found the relative risk of progression from prediabetes to diabetes did not significantly between testosterone and placebo groups. Progression risk was identified in 4 of 598 (0.7%) vs. 8 of 562 (1.4%) at six months, 45 of 575 (7.8%) vs. 57 of 533 (10.7%) at 12 months, 50 of 494 (10.1%) vs. 67 of 460 (14.6%) at 24 months, 46 of 359 (12.8%) vs. 52 of 330 (15.8%) at 36 months, and 22 of 164 (13.4%) vs. 19 of 121 (15.7%) at 48 months (omnibus test, P = .49).

Further results showed the risk of glycemic remission among those with diabetes at baseline did not significantly differ between the testosterone and placebo groups. Changes from baseline in fasting glucose or HbA1c concentrations were also similar among testosterone- and placebo-treated groups in those with either prediabetes or diabetes at baseline. Post-hoc sensitivity analysis of the primary and secondary events occurring within 30 days or 365 days after stopping treatment exhibited similar results to the primary analyses.

Based on these data, Bhasin and colleagues indicated the study results do not support the use of TRT alone in the prevention or treatment of diabetes in men with hypogonadism. Still, they could help weigh its benefit-risk profile for each individual.

The trials findings may be useful in weighing the potential benefits of TRT in middle-aged and older men with hypogonadism who have prediabetes or diabetes, investigators wrote.

References

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Testosterone Ineffective in Preventing Diabetes in Men with Hypogonadism - MD Magazine

Testosterone replacement therapy (TRT) is a commonly sought treatment for men suffering from hypogonadism, a condition characterized by low levels of testosterone. While TRT has been linked to various benefits including increased sex drive, improved bone density and muscle mass, and alleviation of hypogonadism symptoms, recent studies challenge the belief that TRT can play a role in preventing the progression of prediabetes or diabetes in these men.

The TRAVERSE Diabetes Study, a comprehensive research endeavor involving 5204 participants across 316 trial sites, has provided crucial insights into the effectiveness of TRT for metabolic health. The primary aim of the study was to explore whether TRT could halt the progression from prediabetes to diabetes or enhance glycemic control among those already diagnosed with diabetes.

Contrary to previous evidence, the study found that TRT did not significantly affect the risk for progression to diabetes, glycemic remission, or changes in glucose and A1c levels. Furthermore, the progression to diabetes did not differ between groups, and no significant differences were observed in glycemic improvement among men with diabetes.

This indicates that while TRT may be beneficial in treating the symptoms of hypogonadism and improving overall quality of life, it does not appear to have metabolic benefits. As such, the authors of the study concluded that TRT should not be used as a singular therapeutic intervention to prevent or treat diabetes in men with hypogonadism.

Interestingly, the study also highlighted the high rates of testosterone use, even in the absence of proven metabolic benefits. This suggests that men and healthcare providers may need to reassess the use of TRT, particularly if the primary goal is to prevent or manage diabetes. Moreover, it underscores the importance of holistic treatment plans that encompass lifestyle changes and other medical interventions.

While TRT may not be effective in preventing diabetes progression, it is important to note its role in managing male fertility in hypogonadal patients. Testosterone plays a key role in regulating body functions in men. However, traditional TRT can have negative effects on male fertility. Recent advances in research have shed light on new methods of administration and the usage of ancillary medications to maintain fertility in hypogonadal patients.

TRT can be administered in various forms such as gel, injections, patches, buccal patches, capsules, nasal gel, and pellets. Each type has its own set of advantages and disadvantages, and the choice of administration should be tailored to the individuals needs and lifestyle. As with any medical intervention, the potential benefits and risks must be weighed carefully.

In conclusion, while TRT can help manage symptoms and improve the quality of life for men with hypogonadism, it does not show any significant benefit in slowing the progression of prediabetes or diabetes. It is essential for healthcare providers to convey this to patients and to develop comprehensive treatment plans that address the patients overall health and wellbeing.

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Testosterone Replacement Therapy (TRT) and Diabetes: What You Need to Know - Medriva

Menopause is something we usually associate with women and is a condition that marks the end of the female menstrual cycle. However, male menopause, or andropause, is a condition that involves aging-related hormone changes in men, according to the Mayo Clinic. The new phenomenon sees testosterone levels gradually decrease by one percent every year once a man reaches the age of 40. The symptoms are similar to those experienced by women during menopause, like, reduced libido, fatigue and decreased muscle mass. There are solutions to mitigate the decline in testosterone levels like injections, oral medication, creams and over-the-skin patches. Natural solutions to maintain testosterone levels include certain lifestyle changes like regular exercise, healthy eating and adequate sleep. Research in Obesity Reviews shows that obesity can lead to lower testosterone levels, with weight loss being another to manage symptoms.

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Understanding Andropause: Men's Answer To Menopause | Lifestyle | theweeklyjournal.com - The Weekly Journal

If you want to gain a good picture of a man's overall health, measure his testosterone levels. Testosterone isn't just important for libido, strength, and energy it also plays a role in bone health, cardiovascular health, and the immune system. And increasingly, research suggests the hormone is a reliable indicator for disease and longevity.

Researchers have found that men with low testosterone are more likely to suffer from a number of ailments, from heart attacks to diabetes and they may not live as long.

Theres a clear association between testosterone and mortality, says Hugh Jones, an endocrinologist for the Barnsley Hospital NHS Foundation Trust and a professor at the University of Sheffield in England.

So what does this mean for the roughly quarter of men over 40 who have low testosterone? And is it possible to ward off some of the negative health effects associated with low T?

In 2022, scientists at Baylor University and the University of Texas at San Antonio took a deep dive into the relationship between testosterone and early death. Pulling up records for 10,225 patients who had participated in the National Health and Nutrition Examination survey between 1999 and 2004, the researchers found that the lower a mans testosterone levels, the more likely he was to die of disease before 2019. That likelihood was especially high for heart disease, but lower testosterone was also associated with a higher chance of dying from respiratory disease and Alzheimers.

Previous research supports these findings. A 2021 study published in the journal European Urology Open Science found that among 1,792 men who filled out a national survey between 1999 and 2014, those with low testosterone were more than twice as likely to be dead by 2015 compared to men with higher testosterone levels. They were also more likely to have BMIs in the obese category, diabetes, high blood pressure, and risk factors for heart disease.

So do these studies mean that low testosterone causes disease and early death?

Yes and no, Jones says. In his own research, hes found that low testosterone does seem to worsen mens health. In one study, Jones and his colleagues looked at almost 1,000 men with coronary artery disease, in which arteries that supply blood to the heart become dangerously narrow. They compared this population to men who did not have heart disease and found that the men with coronary artery disease had lower overall testosterone.

Additionally, low testosterone was one of the most reliable predictors of death in both groups, surpassed only by weakening of the heart muscle tissue. Men with low T were more than twice as likely to die due to a cardiovascular problem compared to men with normal testosterone levels.

These same scientists then followed 500 patients with diabetes over a period of six years. They found that by the end of the study, 17.2% of patients with low testosterone levels had died, compared to 9% of patients with testosterone in the normal range.

In a different study, Hugh and his colleagues were able to partially reverse the relationship between low T and higher mortality risk from diabetes in a subset of men who received testosterone replacement therapy. In that population, 8.6% of patients died by the end of the study compared to 19.2% who did not receive treatment.

It may be that low testosterone does put you in a position where you have health consequences, Jones says. However, the relationship is likely more complicated than that, he adds. In many cases, disease can actually be what causes low T, which could drive the link between low T and death in many cases.

Disease likely lowers testosterone as the body diverts resources away from the reproductive system towards keeping the body healthy. In addition, major causes of death, such as heart disease and diabetes, are often associated with higher body weight, which may exert its own dampening effect on testosterone because fat cells convert testosterone into estrogen. That can create a negative feedback loop, Jones says: If you have a disease, it may lower your testosterone, which may make that disease worse.

So why does low testosterone worsen disease? The answer to this question is murky, but scientists have a few ideas.

One of them has to do with inflammation, the bodys response to acute illness or injury, in which the immune system releases chemicals and blood cells to fight foreign invaders and heal itself. In the short term, inflammation is a good thing, but chronic inflammation puts stress on the body, making it more susceptible to conditions like heart disease and diabetes.

Testosterone is what scientists call an immune modulator, Jones says after inflammation is no longer needed, it reduces the number of inflammatory proteins called cytokines in the body. So low T could mean the body is worse at tamping down inflammation.

Another possible explanation: In animal studies, testosterone seems to impact the way the body stores fat, Jones says. Rodents with normal testosterone tend to store fat under the skin, whereas those with lower testosterone tend to store more fat around their organs and within the walls of their arteries. In humans, fat stored in these areas is a major predictor of deadly conditions like heart disease.

If you do have low testosterone or suspect that to be the case, you dont need to panic, says Michael Muehlenbein, Ph.D., a biological anthropologist studying evolutionary endocrinology at Baylor University.

Low testosterone may be a predictor of mortality in some cases, he says, but the relationship is not necessarily causal.

Besides, what constitutes low testosterone is a controversial question, and many men who have testosterone levels below the normal range remain healthy.

Still, its a good idea to get your levels checked out if youre experiencing symptoms such as erectile dysfunction, reduced libido, or fatigue. And if you do have low low testosterone, it may be worth talking to your doctors if it could be the result of another condition. That may then inform whether you should start testosterone replacement therapy.

The trick will be determining if low T is a cause of a disease which would then potentially warrant hormone adjustment or is a consequence of having the disease, Muehlenbein says.

Link:
Low Testosterone May Lead To Early Death. Here's What That Means For You - Fatherly

Search results

The search strategy identified 214 studies and 6 additional papers were identified through other sources for a total of 220 studies. After removing the duplicates, 184 studies were screened of which 152 were excluded based on title and abstract. Full text of the 32 selected studies was obtained. 14 studies were excluded: 4 studies were conducted on animal models, 10 didnt evaluate TT and LH levels. The PRISMA flow diagram is presented in Fig.1. Complessively, 18 records fulfilled the inclusion criteria and were included in the final analysis14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31.

PRISMA flow diagram. TT: Testosterone; LH: Luteinizing Hormone.

Eighteen studies met the inclusion criteria and were included in this analysis, overall 1,575 male patients with Covid-19 infection and 886 male controls. According to the severity of the disease, 823 patients were classified as presenting moderate disease and 500 as having severe disease. Patients enrollment ranged between 2020 and 2022. 15 studies14,17,18,19,20,21,22,24,25,26,27,28,29,30,31 exhibited a prospective cohort design and 3 studies reported a retrospective cohort design15,16,23. The studies included were conducted in Turkey14,17,21,22,25,29 Italy15,16,26,27,28 China24,30,31 USA18, Greece20, Russia19, Austria23. Among the studies included, 11 were controlled16,17,19,20,21,24,25,28,29,30. Collected data included testosterone levels 14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31, LH levels14,17,19,22,23,24,28,29,30, IL-6 levels15,23,26,27,28,30,31, lymphocytes count14,15,16,23,24,26,27,28,30,31, D-dimer levels14,15,16,20,24,26,27,31. The characteristics of the 18 studies included are presented in Table1.

Out of n=1814,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31 studies encompassed in the systematic review, n=1016,17,19,21,22,24,25,28,29,30 were further meta-analytically compared with regards to mean TT levels variations between Covid-19 and control populations. Of note, at this preliminary assessment, there was considerable heterogeneity across each single study with I2 98.45%, Q (9): 580.22, p<0.00. Publication bias was initially assessed by Galbright and Funnel plot (Suppl. Fig. 1). Inspection of both plots suggested that there was no small-study effect with the smaller studies tending to have higher SMD variability, suggesting absence of publication bias (Egger test, p=0.96). Additionally, the Trim and Fill method suggested that no studies would have needed to be included to remove residual asymmetry from the funnel plot. The main contribution to study heterogeneity was indeed identified by sub-group analysis summarized in Suppl. Fig. 2. Interestingly, year of publication which in this case is directly associated with the progression of the Covid-19 pandemic exhibited a significant ascending influence on SMD observed, while no further study design nor cumulative sample size of patients accrued was associated with the observed heterogeneity. The effect of publication year was further highlighted at cumulative meta-analysis sorted by year, where increasing variations in SMD of TT levels across the studies were observed (Suppl. Fig. 2). However, as per sensitivity analysis, the leave-one-out analysis suggested acceptable variation along the cumulative SMD observed when clustering the data by publication year. According to predefined random-effects model, we found a significant reduction in the SMD of testosterone levels in Covid-19 patients compared to controls (3.25, 95%CI 5.93, 0.57, p=0.00, I2=98.45%). The difference was even higher when examining men with severe Covid-19 (5.04, 95%CI 8.82, 1.26, p=0.00, I2=96.60%) (Fig.2).

Forest plot for Standardized Mean Difference (SMD) across studies presenting serum Total Testosterone (TT) in Covid-19 male patients vs. male control (A), clinically severe Covid-19 patients vs. control (B), clinically severe Covid-19 vs. clinically moderate Covid-19 patients (C) and, Covid-19 related deaths vs. Covid-19 survivor patients (D).

Additionally, within the Covid-19 population, we assessed patients stratified by severity of clinical manifestations. As further evidence, compared with patients exhibiting moderate Covid-19 symptoms, patients with more severe sequelae exhibited lower levels of testosterone showing a slight yet significant absolute higher SMD (3.53nmol/L, 95%CI 5.11, 1.95, p=0.00, I2=88.19%).

This was corroborated across the n=314,15,18 experiences which reported outcomes stratified according Covid-19 survivors and non-survivors, confirming a similar overall decrease in SMD serum TT levels (3.04, 95%CI 4.05, 2.04, p=0.42, I2=0.00%) (Fig.2).

Finally, in order to explore the remaining heterogeneity observed, we investigated the role of patient available comorbidities or inflammatory/haemato-chemical variables retrieved to the SMD estimates by meta-regression analysis. As expected, there was a direct correlation between increasing BMI of the Covid-19 population and the SMD observed across the studies (Coeff. 2.48, SE: 1.15; p=0.033; Suppl. Fig. 3). Moreover, the sole haemato-chemical confounder significantly associated with TT variation was the absolute lymphocyte count depicting an inverse trajectory with the SMD observed across the studies (Coeff. 7.37, SE: 2.19; p=0.001; Suppl. Fig. 3).

Regarding LH levels, only n=717,19,22,24,28,29,30 studies reported the needed information to further compare the overall populations and the sub-groups assessing the outcomes according to the severity of Covid-19 clinical manifestations. A considerable heterogeneity was documented also in this setting with I2 95.60%, Q(6): 136.32, p<0.02. Additionally, the inspection of both Galbright and Funnel plots suggested that there was a significant small-study effect with the smaller studies tending to have higher SMD variability, suggesting the existence of higher risk of bias among the publications assessed (Egger test, p=0.035). However, the Trim and Fill method suggested that only n=1 study would have needed to be included to remove residual asymmetry from the Funnel plot (Suppl. Fig. 4). This preliminary finding was further confirmed at sub-group analysis where the size of the sample analysed was significantly associated with greater variability in the pooled SMD yet not being influenced by the publication year like previously observed (Suppl. Fig.4).

In contrast to TT levels, the effect on cumulative LH variations was non-significant nor clinically relevant between Covid-19 cases and matched controls (SMD: 0.69, 95%CI 0.56, 1.94, p=0.00, I2=95.60%) ranging along the null-effect line from 3.55, 95%CI 2.64, 4.46, to 2.53, 95%CI 4.73, 0.33 in the study of Cinislioglu et al.17 and Xu et al.30 respectively. This was also true when comparing controls with the n=317,28,30 studies with more severe Covid-19 population (SMD: 0.41, 95%CI 2.37, 3.19, p=0.00, I2=95.54%) (Fig.3).

Forest plot for Standardized Mean Difference (SMD) across studies presenting serum Luteinizing Hormone (LH) levels in the Covid-19 patients vs. control (A), clinically severe Covid-19 patients vs. control (B), and clinically severe Covid-19 vs. clinically moderate Covid-19 patients (C).

Furthermore, at sensitivity analysis through leave-one-out assessment there was no single study effect size which would have significantly impaired the observed pooled results if omitted from the analysis (Suppl. Fig. 5).

At meta-regression on quantitative variables available, the relative percentage of Covid-19 patients with active smoking status was the sole factor influencing the pooled SMD estimate for serum LH levels (Coeff. 0.08, SE: 0.01; p=0.001; Suppl. Fig. 6).

Finally, when sub-analyzing within the Covid-19 severity of clinical manifestations, there was no significant or clinically relevant SMD across the n=5 studies included14,17,26,28,30 0.28 (95%CI 1.55, 1.00, p=0.00, I2=88.52%).

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Systematic review and meta-analysis of serum total testosterone and luteinizing hormone variations across ... - Nature.com

American tenor Holden Madagame is set to make history this week when he takes the stage as the first ever transgender person to sing Mime in a production of Siegfried. Here he looks back at the effect transitioning while pursuing a career in music had on his voice and explores his new position as a trans role model in opera

The way that testosterone works is unique as far as hormones go. Many effects of testosterone are not reversible, the change in vocal range being one of them. I started taking testosterone in 2014, about a year after arriving in Germany. I had completed my Bachelor of Music at the University of Michigan and my intention had been to get my Master of Music, then pursue a career in opera but deciding to take testosterone changed this.

When I started to take testosterone, there were no role models I could look to to guide me on my journey. In the last decade there have been more trans people in opera who take hormones and a few studies on the subject, but there are still relatively few singers who take testosterone because of the unpredictable and irreversible effects on the voice. For this reason, I took a long time deciding whether taking testosterone was viable for me.

The process of an adult AFAB (assigned female at birth) voice taking testosterone is relatively similar to an AMAB (assigned male at birth) person whose voice breaks when they are a teenager. The difference being that an adult AFAB persons vocal cords are less flexible and more solidified in their development than an AMAB persons cords. This is not surprising considering a younger body can regenerate in ways that older bodies cannot. Practically speaking, this means that an AFAB voice on testosterone undergoes a similar period of change, except the larynx is not growing in size as the vocal cords are thickening. For me, this caused a large amount of hoarseness and a significant decrease in my vocal stamina for about a year, but these effects decreased over time.

My way of dealing with these changes was and continues to be relatively simple: patience. Although I would sing occasionally, I knew from my own kinaesthetic awareness of my voice that there were diminishing returns. The neuroticism that could have built up because of this was not worth it to my mental health nor to my overall artistic and creative health so I decided instead to be patient and sing music I enjoyed to get through this exciting and terrifying period of my life. Artistic longevity cannot be maintained unless we as singers take care of our mental health as well as our enthusiasm for making art.

Steve Gregson

Another crucial element which helped me remain patient during this transition was the unique thing that I have been able to give to the world: my existence as a trans opera singer on testosterone makes it possible for other trans singers looking into hormone therapy to see themselves existing and thriving in an industry that is well-known for being normative and unwelcoming.

So how can we create a more welcoming environment for trans performers? Fortunately, the answer is simple. Unfortunately, it requires fundamental changes in how we teach, cast, produce and compose opera. As with any accessibility issue, creating a place for marginalised groups creates better conditions for everyone, with some fundamental aspects being fair wages, fair conditions and transparency. Without these, we create classist, sexist, racist, homophobic, and transphobic conditions without even meaning to.

A seemingly daunting, but easily broken-down idea to consider is less restrictive adherence to gender stereotypes. Adherence to these embodied genders in singers makes it difficult for those who divert slightly from the gender assigned at Fach to succeed in the opera industry. This is not only true for trans people (who of course are most affected by this), but for cisgender people too. There are countless rules for every Fach, for example the well-known rule of the trade that a soprano cannot wear trousers to an audition they should appear as feminine as possible an atrocious anachronism that the industry continues to perpetuate.

The reality of changing these expectations is quite easy for any person in a position of teaching, casting, directing, producing, etc. but we as singers do not have the power to do this without jeopardising our careers. Often singers who do not adhere to industry standards end up sticking to new or popular music because it is more accepting and open about gender.

My recent work with Regents Opera on their production of Rheingold and upcoming production of Siegfried stands as proof that anyone can make efforts to change industry standards. As an artist I am able to be my authentic self in rehearsals, I am paid fairly with clear rehearsal times and adequate breaks, the company is transparent about any given situation and the company has cast singers outside the status quo or the expected choice. My work with Regents Opera has over time allowed me to grow as an artist and feel accepted in the work that I do and, as far as Im aware, I will on 4 February, with the opening night of Regents Opera's Siegfried at London's Freemasons Hall become the first transgender person ever to sing Mime in a production of Siegfried. I am so proud of myself and of Regents Opera for this history-making first.

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Holden Madagame on testosterone, transitioning and the art of patience - Classical-music.uk

SALT LAKE CITY, Feb. 2, 2024 /PRNewswire/ -- Lipocine Inc.(NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that commercialization of TLANDO in the U.S. has been transitioned to its licensee Verity Pharmaceuticals, effective February 1, 2024, enabling the continuity of patient access to TLANDO. TLANDO is the first and only oral testosterone replacement therapy (TRT) option approved by the US Food and Drug Administration (FDA) that does not require dose titration.

In January 2024, Lipocine and Gordon Silver Limited entered into an exclusive license agreement under which Verity Pharma will market TLANDO inthe United States and, if approved, in Canada. Under the terms of the license agreement, Lipocine has received the second tranche of the $11 million license fee, $5 million. In addition, per the license agreement, Gordon Silver Limited is to make license fee payments of $2.5 million and $1 million no later than January 1, 2025, and January 1, 2026, respectively.

About TLANDO

TLANDO is approved by the FDA as a testosterone replacement therapy ("TRT") in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). TLANDO was developed using Lipocine's proprietary Lip'ral drug delivery technology platform.

For full prescribing information, please visitwww.TLANDO.com.

IMPORTANT SAFETY INFORMATION

TLANDO (testosterone undecanoate) capsules, for oral use, CIII

Initial U.S. Approval: 1953

IMPORTANT SAFETY INFORMATION

WARNING: BLOOD PRESSURE INCREASES (See Boxed Warning on Product Label for more information)

TLANDO can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease.

Before initiating TLANDO, consider the patient's baseline cardiovascular risk and ensure blood pressure is adequately controlled.

Three weeks after initiating therapy monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension.

Re-evaluate whether the benefits of TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment. Due to this risk, use TLANDO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.

TLANDO INDICATIONS AND USAGE

TLANDO (testosterone undecanoate) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

Primary hypogonadism (congenital or acquired)

Hypogonadotropic hypogonadism (congenital or acquired)

LIMITATIONS OF USE

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

CONTRAINDICATIONS

TLANDO is contraindicated in:

Patients with carcinoma of the breast or known or suspected carcinoma of the prostate.

Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman.

Known hypersensitivity to testosterone undecanoate or any of TLANDO's ingredients.

Men with hypogonadal conditions, such as "age-related hypogonadism", that are not associated with structural or genetic etiologies. The efficacy of TLANDO has not been established for these conditions, and TLANDO can increase BP that can increase the risk of MACE.

WARNINGS AND PRECAUTIONS

Increase in Blood Pressure: In Study 18-001, TLANDO increased systolic BP after 4 months of treatment by an average of 4.3 mmHg based on ambulatory blood pressure monitoring (ABPM) and 4.8 mmHg from baseline based on blood pressure cuff measurements [see Adverse Reactions (6.1)].

These BP increases can increase the risk of major adverse cardiovascular events (MACE), with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease.

In some patients, the increase in BP with TLANDO may be too small to detect but can still increase the risk for MACE.

Before initiating TLANDO, consider the patient's baseline cardiovascular risk and ensure blood pressure is adequately controlled. Check BP approximately 3 weeks after initiating TLANDO and periodically thereafter. Treat new-onset hypertension or exacerbations of pre-existing hypertension. Re-evaluate whether the benefits of continued treatment with TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease.

Polycythemia: Increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of TLANDO. Check hematocrit prior to initiating TLANDO. Evaluate hematocrit approximately every 3 months during the first year of treatment, and then every 6 months thereafter while the patient is taking TLANDO. If hematocrit becomes elevated, stop TLANDO until hematocrit decreases to an acceptable concentration. If TLANDO is restarted and again causes hematocrit to become elevated, stop TLANDO permanently. An increase in red blood cell mass may increase the risk of thromboembolic events.

Cardiovascular Risk: Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men.

TLANDO can cause BP increases that can increase the risk of MACE. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO.

Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer: Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms. Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer, including measurement of prostate specific antigen (PSA), prior to initiating and during treatment with androgens.

Venous Thromboembolism: There have been post marketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone replacement products such as TLANDO. Evaluate patients who report symptoms of pain, edema, warmth, and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue TLANDO and initiate appropriate workup and management.

Abuse of Testosterone and Monitoring of Serum Testosterone Concentrations: Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions.

If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.

Not for Use in Women: Due to lack of controlled studies in women and the potential for virilizing effects, TLANDO is not indicated for use in women. Potential for Adverse Effects on Spermatogenesis: With large doses of exogenous androgens, including TLANDO, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) possibly leading to adverse effects on semen parameters including sperm count. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO.

Hepatic Adverse Effects: Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. TLANDO is not a 17 alpha-alkyl androgen and is not known to produce hepatic adverse effects associated with 17-alpha-alkyl androgens.

Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). If these occur, promptly discontinue TLANDO while the cause is evaluated.

Edema: Androgens, including TLANDO, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease [see Adverse Reactions (6.1)]. In addition to discontinuation of the drug, appropriate work up and management of edema may be required.

Sleep Apnea: The treatment of hypogonadal men with testosterone products may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.

Gynecomastia: Gynecomastia may develop and persist in patients being treated for hypogonadism.

Lipid Changes: Changes in serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of testosterone therapy. Monitor the lipid profile periodically after starting testosterone therapy.

Hypercalcemia: Androgens, including TLANDO, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Monitor serum calcium concentrations periodically in these patients.

Decreased Thyroxine-binding Globulin: Androgens, including TLANDO, may decrease concentrations of thyroxin-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of triiodothyronine (T3) and thyroxine (T4). Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Increases in Prolactin: Increases in serum prolactin have been reported in patients treated with TLANDO in clinical trials. Evaluate serum prolactin levels prior to initiating treatment with TLANDO. Re-evaluate serum prolactin levels 3 to 4 months after starting treatment. If serum prolactin remains elevated, discontinue TLANDO.

ADVERSE REACTIONS

The safety of TLANDO was evaluated in 2 clinical studies in a total of 233 men.

Study 18-001: 138 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 4 months.

Study 16-002: 95 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 24 days.

The most commonly reported adverse reactions ( 2%) were: increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, weight increased, headache, and musculoskeletal pain.

DRUG INTERACTIONS

Insulin: Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.

Oral Anticoagulants: Changes in anticoagulant activity may be seen with androgens. Frequent monitoring of INR and prothrombin time may be necessary in patients taking anticoagulants, especially at the initiation and termination of androgen therapy.

Corticosteroids: The concurrent use of testosterone with corticosteroids may result in increased fluid retention and should be monitored cautiously, particularly in patients with cardiac, renal or hepatic disease.

Drugs that May Also Increase Blood Pressure: Some prescription drugs and nonprescription analgesic and cold medications can increase blood pressure. Concomitant administration of these medications with TLANDO may lead to additional increases in blood pressure.

USE IN SPECIFIC POPULATIONS

Pregnancy: TLANDO is contraindicated in pregnant women and not indicated for use in females. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies (see Data) and its mechanism of action. Exposure of a female fetus to androgens may result in varying degrees of virilization. In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies did not meet current standards for nonclinical development toxicity studies. Lactation: TLANDO is not indicated for use in females.

Females and Males of Reproductive Potential: During treatment with large doses of exogenous androgens, including TLANDO, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis. Reduced fertility is observed in some men taking testosterone replacement therapy. The impact on fertility may be irreversible. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids.

Pediatric Use: The safety and effectiveness of TLANDO 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.

Geriatric Use: There have not been sufficient numbers of geriatric patients in controlled clinical studies with TLANDO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. Of the 95 patients enrolled in Study 16-002, the 24-day major safety and effectiveness study utilizing TLANDO, 16 (16.8%) were over 65 years of age. Additionally, there is insufficient long-term safety data in geriatric patients utilizing TLANDO to assess the potentially increased risk of cardiovascular disease and prostate cancer.

Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and hypertension.

DRUG ABUSE AND DEPENDENCE

TLANDO contains testosterone undecanoate, a Schedule III controlled substance.

Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids may be abused by athletes and bodybuilders.

Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression.

The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility.

The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities.

The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.

Withdrawal symptoms can be experienced upon abrupt discontinuation in patients with addiction. Withdrawal symptoms include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Drug dependence in individuals using approved doses for approved indications has not been documented.

For more information, call 1-844-996-7833.

Please see full Prescribing Information, including Boxed Warning and Medication Guide.

About TLANDO XR

TLANDO XR (also known as LPCN 1111) is a next-generation, novel ester prodrug of testosterone comprised of testosterone tridecanoate (TT) which uses Lipocine's proprietary delivery technology to enhance solubility and improve systemic absorption. Lipocine has successfully completed a Phase2bdose finding study in hypogonadal men. Results suggested that the primary objectives were met, including identifying the dose expected to be tested in a planned Phase 3 study that would be required for FDA approval.

About Verity Pharma

Verity Pharma is a specialty pharmaceutical company focused on delivering meaningful solutions to healthcare professionals and their patients.

Verity Pharma works with best-in-class global pharmaceutical manufacturing partners to ensure that product quality and availability is a constant deliverable. The company is also committed to supporting programs, initiatives, and organizations that help improve health, expand research opportunities and promote education within the healthcare community. Learn more atwww.veritypharma.com.

About Lipocine

Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products for CNS disorders. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnering. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs.

Lipocine's clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN1154, for rapid relief of postpartum depression, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of non-cirrhotic NASH. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, pleasevisitwww.lipocine.com.

Forward-Looking Statements

This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Verity Pharma's development and commercialization of TLANDO and TLANDO XR, the amount of the license fee, milestone payments, and royalty payments we will ultimately receive, Verity Pharma's ability to grow the TLANDO franchise, our product development efforts, the application of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, our development of and filing of a NDA with the FDA for LPCN 1148, and the potential uses and benefits of our product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful in developing product candidates to treat CNS disorders, we may not have sufficient capital to complete the development processes for our product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website atwww.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

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SOURCE Lipocine Inc.

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Lipocine Announces Continued Commercialization of TLANDO through Verity Pharmaceuticals - BioSpace

In this video, Austin Thompson and Nannan Thirumavalavan, MD, discuss the background and key findings from the study, Low Serum Testosterone is Associated with an Increased Risk of First-time Nephrolithiasis in Men Without Testosterone Replacement Therapy. Thompson is a third-year medical student at Case Western Reserve University in Cleveland, Ohio, and Thirumavalavan is a urologist at University Hospitals in Cleveland, Ohio.

Video Transcript:

Could you describe the background for this work?

Thompson: The background from this work came from looking through the literature. We've known for a long time that as men aged testosterone decreases. But there's some recent articles showing that in younger men as well, we're starting to see low levels of testosterone. We use the AUA definition of below 300 ng/dL. From there, reading about kidney stones, as well, and the prevalence of kidney stones increasing over the years, we started to look to see what link may exist between those 2. What we found in the literature was that there's a lot of discrepancy with studies saying that low testosterone may be associated with kidney stones. There are studies that have not found an association. And then there are studies that have also shown that higher levels of testosterone may also be associated with kidney stones. So, with all that in mind, we felt that the TriNetX database, which is multi-institutional, even includes data from multiple countries, may be a good way to address this discrepancy that you see in the literature, because the ability to really apply good matching categories based on comorbidities, medications, with some of the other larger databases, to my knowledge, you're not able to do and things of that nature.

Thirumavalavan: Certainly, the biggest question that comes out of this is, is it the fact that many of the conditions that cause kidney stones also cause low testosterone, or are associated with it? For example, obesity, high blood pressure, or diabetes, metabolic syndrome, all of that is associated with low testosterone levels and is associated with kidney stones. The sicker you are, the more likely you are to have both of those things. So, the goal with this study is to control for as many of those factors as we can using TriNetX data and see if testosterone is still independently predictive of a first time kidney stone episode.

What were the notable findings from this study?

Thompson: The main finding is that when you look at men with low testosterone, grouped 18 and above, we found that there is an association between low testosterone and kidney stone encounter diagnoses. Then we subgrouped it as well by age cohorts. We also saw that in when 25 and above this association persists. When you look at some of the other studies that have investigated this is that men below the age of 40, no association has been seen with low testosterone and kidney stones. I think that the reason why we may have seen an association in younger men was because the scope of the TriNetX database were able to capture more patients in this younger age group, which may have allowed us to better investigate this association in men under 40.

This transcription has been edited for clarity.

Note: This project was supported in part bythe Clinical and Translational Science Collaborative of Northern Ohio, which is funded by the National Institutes of Health, National Center for Advancing Translational Sciences, Clinical and Translational Science Award grant, UM1TR004528.The content issolely the responsibility of the authors and does not necessarily represent the official views of the NIH.

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Experts discuss the association between low testosterone and kidney stones - Urology Times

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Lipocine (NASDAQ:LPCN) has entered a license agreement for its Tlando oral testosterone replacement therapy (TRT) with Verity Pharma.

The agreement will see Verity market Tlando in the U.S. - where it was approved in 2022 - and in Canada when it gets regulatory clearance. Verity will also hold development and commercialization rights to LPCN 1111 (Tlando XR), a "next generation" oral product candidate for TRT. It will be responsible for regulatory and marketing obligations in the U.S. and Canada.

Lipocine will get a $11M license fee and up to $259M in development and commercialization milestones. It retains rights to the Tlando franchise outside the US and Canada.

Antares Pharma - now part of Halozyme Therapeutics (HALO) - held exclusive licensing rights to Tlando at the time of the therapy's final approval by the U.S. FDA in 2022.

Shares of Lipocine (LPCN) rose as much as 12% premarket on Thursday

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Lipocine licenses Tlando testosterone therapy to Verity Pharma (NASDAQ:LPCN) - Seeking Alpha

Even though my Hone physician told me I qualified for testosterone replacement therapy, I was hesitant to start. My husband is in grad school, so the cost of treatment made me reluctant to dive in. I put TRT on the back burner, and decided to start my fitness journey without hormone therapy.

In March 2023, I went all in. I didnt just want to lose weight, I wanted to gain muscle, too. Instead of focusing solely on weight loss measures like doing cardio and eating at a caloric deficit, I upped my protein intake to 190 grams per day and did strength training with a trainer four days a week.

By June, I lost around 20 pounds. But I just couldnt shake my low energy and sleep problems, which were affecting my motivation. So, with a bit of encouragement from a friend who saw me struggling, I decided to retest my hormones with Hone and start TRT.

My Hone physician said I was doing all the right things, but my T levels only clocked in at 367 ng/dL, which isnt optimal for my age. To get my hormones into the normal range, and improve my energy, Id need TRT. I was prescribed subcutaneous injections twice a week, with anastrozole to keep my estrogen levels in check.

In just three weeks, I felt more motivated to stick to my workout and diet. And, I was less irritable. I stopped feeling FOMO when I decide to skip nights of drinking with my friends.

Three months into treatment, my testosterone levels shot up to 1,178 ng/dL. The muscles in my shoulders bulked up and rounded outa physique that can take even the most committed gym-goers years to achieve. My stubborn belly fat practically melted away, revealing a solid four-pack.

Now seven months into treatment, I am around 190 pounds and have 9.4 percent body fat. I have a renewed sense of purpose, and I hit the gym six days a week. Im so close to my goal of getting a six pack.

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TRT Helped Me Lose Fat and Gain Muscle at the Same Time - The Edge

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