Martin M. Miner, MD, presented “TRAVERSE: Meaning of the Testosterone Safety Trials” during the 24th Future Directions in Urology Symposium in August 2024 in Colorado Springs, Colorado.

How to cite: Miner, Martin M. TRAVERSE: Meaning of the Testosterone Safety Trials.” August 2024. Accessed Nov 2024. https://grandroundsinurology.com/traverse-meaning-of-the-testosterone-safety-trials/

TRAVERSE: Meaning of the Testosterone Safety Trials  Summary

Martin M. Miner, MD, reviews testosterone safety trials and recent data on the cardiometabolic effects of testosterone, addressing concerns from the FDA about off-label testosterone use among aging men. The TRAVERSE trial, conducted in response to these concerns, examines whether testosterone therapy increases the risk of myocardial infarction or stroke.

In this 12-minute presentation, Dr. Miner provides a comprehensive review of studies from 1940 to 2014, which found minimal evidence suggesting cardiovascular risks associated with testosterone. However, key studies released in 2013-2014 raised concerns about testosterone therapy, indicating a potential increased risk of non-fatal myocardial infarctions. In response, the FDA issued a directive in 2015, leading to the large-scale TRAVERSE trial, a double-blind, placebo-controlled trial that assessed testosterone gel effects over five years.

The TRAVERSE study is notable as the longest randomized, controlled trial on testosterone safety among hypogonadal men to date. Findings indicate that testosterone therapy poses low cardiovascular risk, improves sexual health, and has no significant impact on prostate cancer risk or progression. This suggests that normalized testosterone levels may reduce risks of mortality and adverse cardiovascular events, without elevating prostate cancer concerns.

The Future Directions in Urology Symposium (FDUS) is an annual urology think tank and non-CME educational summit that brings together industry figures and experts to discuss the current state of genitourinary care and define future directions in treatment. Dr. Dreicer delivered this educational activity during the 24th iteration of the meeting in August 2024 in Colorado Springs, Colorado.

ABOUT THE AUTHOR

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Martin M. Miner, MD, is founder and internist at the Lifespan Men’s Health Center and former chair of the Department of Family Medicine for Miriam Hospital in Providence, Rhode Island. He is also a clinical professor of family medicine and urology at the Warren Alpert Medical School of Brown University in Providence. Dr. Miner earned his MD at the University of Cincinnati College of Medicine in Ohio. He completed his residency at Brown University and spent time working with the Indian Health Service Corps and the Public Health Service. Dr. Miner presently holds memberships in the American Academy of Family Physicians, the Rhode Island and Massachusetts Academy of Family Physicians, and the American Urological Association (AUA), and is a Fellow of the Sexual Medicine Society of North America. He is president-elect of the Androgen Society and has participated as a member of the AUA in the development of guidelines for erectile dysfunction, Peyronie's disease, testosterone deficiency, and early screening for prostate cancer. He is the former president of the American Society of Men’s Health. Dr. Miner has published extensively in the areas of erectile dysfunction and cardiovascular disease, benign prostatic hyperplasia, and lower urinary tract symptoms, as well as male sexuality and hormone replacement therapy in men.