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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.

View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocine-announces-continued-commercialization-of-tlando-through-verity-pharmaceuticals-302050012.html

SOURCE Lipocine Inc.

Continue reading here:
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

How to naturally boost testosterone levels for enhanced overall wellness  Fox News

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How to naturally boost testosterone levels for enhanced overall wellness - Fox News

Testosterone treatment didn't offer protection against fractures in men with hypogonadism, a TRAVERSE subtrial indicated.

Compared with placebo, men who were on a testosterone gel actually had a significantly higher risk for fracture (HR 1.43, 95% CI 1.04-1.97), found Peter Snyder, MD, of the University of Pennsylvania in Philadelphia, and colleagues.

During the median 3.19-year follow-up, 91 men on testosterone experienced a clinical fracture compared with 64 men on placebo, excluding fractures of the sternum, fingers, toes, facial bones, and skull (3.50% vs 2.46%), the group wrote in the New England Journal of Medicine.

The researchers were quite surprised to find this, Snyder told MedPage Today, referencing how prior studies have demonstrated that testosterone increases bone structure and therefore might reduce the risk of fracture, in theory.

Testosterone-treated men had a numerically higher rate of all types of fractures compared with placebo, including:

In both groups, most of the fractures endured were associated with trauma, mostly commonly with falls. The most common fracture sites were ribs, wrist, and ankle. "These sites are of clinical significance because fractures at these sites are associated with low bone mineral density and with previous fractures and are therefore considered osteoporotic fractures," the researchers pointed out, adding that these fractures are also tied with increased risk for future fractures and death.

It's "unlikely" that this increased risk for osteoporosis fracture was a direct result of testosterone affecting bone structure and strength, argued accompanying editorial authors Mathis Grossmann, MD, PhD, of the University of Melbourne in Australia, and Bradley Anawalt, MD, of the University of Washington School of Medicine in Seattle. Instead, they think this more likely stemmed from a behavioral change from the testosterone bumping up engagement in physical activities.

Topline TRAVERSE findings, presented at the ENDO 2023 conference, found testosterone was noninferior to placebo for the occurrence of major adverse cardiac events in men with established or at high risk for cardiovascular disease. However, testosterone was linked with a higher rate of a few other risks compared with placebo including atrial fibrillation (3.5% vs 2.4%), acute kidney injury (2.3% vs 1.5%), and pulmonary embolism (0.9% vs 0.5%).

"Finding that testosterone treatment of men with late-onset hypogonadism increases fracture risk, together with the previously reported increased risk of atrial fibrillation and blood clots, outweighs the benefits of this treatment on improving sexual function and, to a lesser degree, walking and mood," said Snyder.

All in all, testosterone treatment of late-onset hypogonadism is simply not worth the risks, he warned other clinicians.

Another recent analysis from the trial found testosterone-treated men didn't have an increased risk for adverse prostate events. However, testosterone replacement therapy was linked with a significant increase in prostate-specific antigen (PSA) values compared with placebo as early as 3 months and persisted to 12 months.

Men ages 45 to 80 (median age 63) were included in the TRAVERSE trial if they had preexisting or high risk of cardiovascular disease, at least one symptom of hypogonadism, and two morning testosterone concentrations of less than 300 ng/dL (10.4 nmol/L) in fasting plasma samples obtained at least 48 hours apart. Those with a serum testosterone concentration of less than 100 ng/dL (3.5 nmol/L) or with conditions that might be worsened by testosterone treatment, like prostate cancer, were excluded. Average baseline BMI was 35.

The full-analysis population included 5,204 participants: 2,601 on testosterone and 2,603 on placebo. Testosterone-treated patients used a transdermal 1.62% testosterone gel with a goal of maintaining a serum testosterone concentration of 350 to 750 ng/dL and a hematocrit under 54%.

The median serum testosterone concentration in the testosterone group increased from 227 ng/dL at baseline to 368 ng/dL by month 6 and remained higher than baseline through year 3.

Some limitations of the study included that physical activity and risk-taking weren't assessed, nor were bone density and structure. Editorialists Grossmann and Anawalt said future studies must include measurements of behavior and physical function affecting fracture risk.

Kristen Monaco is a senior staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, shes worked at the company since 2015.

Disclosures

The trial was supported by AbbVie, Acerus Pharmaceuticals, Endo Pharmaceuticals, and Upsher-Smith Laboratories.

Snyder reported a relationship with AbbVie. Co-authors reported several ties with industry.

Primary Source

New England Journal of Medicine

Source Reference: Snyder PJ, et al "Testosterone treatment and fractures in men with hypogonadism" N Engl J Med 2024; DOI: 10.1056/NEJMoa2308836.

Secondary Source

New England Journal of Medicine

Source Reference: Grossmann M, Anawalt BD "Breaking news -- testosterone treatment and fractures in older men" N Engl J Med 2024; DOI: 10.1056/NEJMe2313787.

Go here to see the original:
Fracture Risk Bumped With Testosterone Therapy in Hypogonadal Men - Medpage Today

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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

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

Prostate Risks Similar for Testosterone Therapy and Placebo  Medscape

Excerpt from:
Prostate Risks Similar for Testosterone Therapy and Placebo - Medscape

Testosterone Replacement Therapy and Prostate Cancer Risk  Medscape

Continued here:
Testosterone Replacement Therapy and Prostate Cancer Risk - Medscape

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.

Read the original here:
TRT Helped Me Lose Fat and Gain Muscle at the Same Time - The Edge

Best Testosterone Boosters in 2024

Want to know more about the best testosterone boosters, how they work, and the research behind them? Read on to find out how the best testosterone boosters work to raise your testosterone levels and find the right brand for your needs.

Pros

Cons

TestoPrime stands out as an all-natural testosterone booster designed to revitalise youthful energy and vitality in men. Its formulation is geared towards boosting both physical and mental energy. This supplement plays a crucial role in supporting protein synthesis, which aids in burning unwanted fat while building lean muscle.

Additionally, TestoPrime enhances motivation by boosting confidence and mood. Its optimised metabolism contributes to effective thermogenesis, aiding in more efficient fat burning.

The distinct advantage of TestoPrime is its daily usability thanks to its natural ingredients. In addition to being one of the best testosterone boosters, TestoPrime also offers a 100% lifetime money-back guarantee, emphasising its confidence in delivering positive results.

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Pros

Cons

D-Bal MAX is an effective testosterone booster for those struggling to gain muscle mass, especially for individuals who are naturally skinny and find it challenging to put on weight. Plus, it may provide the necessary boost to overcome plateaus in bulking efforts.

This supplement is also beneficial for those with a muscular build who want to lose fat without sacrificing muscle size. Additionally, D-Bal MAX is among the best testosterone boosters for people returning to training after a break, helping them reclaim their previously toned physique.

Its designed to support intense workout regimens and is more focused on muscle building and strength enhancement rather than quick weight loss.

>>Check the best prices for D-Bal MAX

Pros

Cons

Testo-Max is a natural testosterone booster designed to enhance muscle building without the need for illegal steroids. Its potent formula, comprising D-Aspartic acid, zinc, magnesium, and vitamins B6, D, and K1, works synergistically to elevate testosterone levels. This elevation leads to significant gains in strength, muscle mass, energy, and overall performance.

Ideal for those seeking to maximise their workouts, Testo-Max ensures explosive strength and insane workout capacity. It may also aid in achieving maximum muscle gains and ultra-rapid recovery times, making it one of the best testosterone boosters for fitness enthusiasts and bodybuilders.

>>Check the best prices for Testo-Max

Pros

Cons

Prime Male is one of the best testosterone boosters tailored for men aged 30 and older, aiming to restore the vigour and vitality of their youth. It works by supporting and elevating testosterone levels, which in turn assists in burning fat, building muscle, and increasing libido.

The supplement is formulated with a blend of 12 essential nutrients, each chosen for its critical role in enhancing health and fitness. Prime Male focuses on holistic vitality, addressing muscle strength, body composition, overall energy levels, and sexual health.

It's particularly effective for those looking to counteract the natural decline in testosterone levels that occurs with age, thereby helping to avoid related health issues.

>>Check the best prices for Prime Male

Pros

Cons

Testogen stands out as the best testosterone booster for fast results. Packed with natural and thoroughly tested ingredients like D-aspartic acid, fenugreek, and zinc, Testogen may support healthy testosterone levels.

The daily routine of taking four capsules each morning might lead to noticeable improvements in energy, mood, focus, and vitality within just two weeks. Additionally, users may expect muscle and strength gains in just one month when incorporated into their regular training program.

>>Check the best prices for Testogen

Pros

Cons

Testosil stands out among the best testosterone boosters tailored for those looking to elevate their exercise performance. It is a favourite among fitness enthusiasts looking to build strength and physical stature.

Additionally, it plays a significant role in reducing muscle damage caused by rigorous workouts by aiding in faster recovery. Beyond physical benefits, Testosil may also improve cognitive functions such as memory and executive functioning.

>>Check the best prices for Testosil

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Cons

XWERKS Rise stands out for its focus on optimising essential nutrient and mineral levels, promoting muscle growth and overall strength. Its formulation is based on natural, proven ingredients that work synergistically to rejuvenate your physical performance.

As one of the best supplements to increase testosterone, it is effective in enhancing ones ability to gain strength and muscle, significantly maximising the results of gym workouts. Users have also reported a notable increase in energy levels, reminiscent of their younger selves but potentially even better.

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TestoFuel is specifically designed as one of the best testosterone boosters for those looking to enhance muscle gains. It is designed to increase testosterone levels, providing the body with essential nutrients needed for this purpose.

This approach not only aids in accelerated muscle growth but might also contribute to an increase in muscle size and strength.

Additionally, TestoFuel may aid in reducing body fat, offering a more comprehensive physical transformation. An important benefit of increased testosterone is the improvement in mood, which aids in staying motivated and focused on fitness goals.

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Provacyl stands out in the market for its unique formulation aimed at boosting testosterone and HGH (Human Growth Hormone) levels, particularly addressing the needs of ageing males. This supplement is crafted with herbs, nutrients, and amino acids designed to stimulate the body's natural hormone production, which tends to decrease with age.

Users have reported experiencing increased energy levels and a greater sex drive, along with improvements in mood and mental focus. Provacyl is also noted for its ability to decrease body fat and increase lean muscle mass, potentially helping to reduce some physical signs of ageing.

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Testodren distinguishes itself in the testosterone booster market with its unique, single-ingredient formula. It contains 500 mg of Furosap, a 100% natural and U.S.-patented compound derived from the Fenugreek herb.

Users of Testodren may expect an increase in overall energy, improved focus and concentration, faster muscle building, enhanced strength and stamina, and easier weight loss.

While the single-ingredient approach is a highlight, it may limit the diversity of benefits compared to multi-ingredient best testosterone supplements like TestoPrime.

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Pros

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11 of the Best Testosterone Boosters for Men in 2024 - HeraldScotland

Undergoing HRT causes various desired outcomes, and one of the possible impacts is the changing of your vocal chords, and thus, your voice.

Hormone replacement therapy (HRT) is a vital part of the gender transition process for many transgender people. While HRT can bring about significant physical and emotional changes, one aspect that often concerns singers or aspiring musicians is its potential effect on the singing voice.

When transmasculine individuals undergo HRT with testosterone, they often experience a significant change in their voice. The hormone leads to vocal masculinisation, which involves the thickening and lengthening of the vocal cords. This results in a deeper, more traditionally masculine voice. The degree of vocal change varies from person to person.

Singers who transition through testosterone may experience challenges in adapting to their new vocal range. It may take time and effort to retrain their voice and develop new vocal techniques to accommodate the lower pitch. Some singers may lose some of their higher vocal range, but with practice and vocal training, they can still sing and perform effectively. It's important to work with a vocal coach or speech therapist who can help navigate these changes.

For people who are transfeminine and take oestrogen, this hormone primarily affects secondary sexual characteristics, such as breast development and fat distribution. Unlike testosterone, oestrogen does not have a significant effect on the voice, meaning that there are generally no significant changes to the vocal range.

To preserve your singing voice while on HRT, especially if you're taking testosterone, you can consider the following strategies:

Taking a low dose of testosterone can help preserve your singing voice compared to a full dose. A lower dose of testosterone results in less dramatic changes in vocal pitch and quality. However, it's important to note that individual factors such as genetics and the duration of hormone replacement therapy (HRT) still influence the effect of testosterone on the voice. While a lower dose might be less impactful, more is needed to guarantee a complete preservation of the original voice. Vocal training and therapy can still be valuable in adapting to any changes.

The amount of testosterone taken can impact the rate and extent of voice changes. If a lower dose is taken, the changes will be more gradual and subtle, allowing some people to maintain a voice closer to their pre-HRT voice. A full dose, on the other hand, can result in more pronounced changes, leading to a deeper, more traditionally masculine voice. However, the extent of the change can vary significantly from person to person, and even with a lower dose, some may still experience noticeable differences in their voice, though to a lesser degree.

It takes time and practice to adapt to a new vocal range. Transgender people undergoing hormone replacement therapy (HRT) should be patient with themselves and practice regularly to strengthen their voices and become more comfortable with their new range.

Regular vocal exercises and warm-ups are essential in maintaining vocal health and flexibility. These exercises can help individuals extend their vocal range and improve their vocal control.

Some people may consider voice surgery. These surgical procedures can achieve a more desired vocal pitch and quality. However, surgery is an irreversible step and should be carefully considered.

Here are some common voice surgeries:

Undergoing HRT can have an impact on a person's singing voice. However, transgender people can maintain their singing abilities and continue their passion for music with determination, vocal training, and support. It's important to understand that the effects of HRT on the voice can vary from person to person. Thus, finding what works best for you is a unique and personal journey that may require patience and perseverance. With the right guidance and effort, it is possible to harmonise your voice with your authentic self.

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How HRT impacts your voice - Will transition affect my singing? - GenderGP

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