Mohit Khera, MD, MBA, MPH, presents “Testosterone and Cardiovascular Risk: TRAVERSE Trial and New FDA Label Change.”
How to cite: Khera, Mohit. “Testosterone and Cardiovascular Risk: TRAVERSE Trial and New FDA Label Change.” February 19, 2025. Accessed May 2025. https://grandroundsinurology.com/testosterone-and-cardiovascular-risk-traverse-trial-and-new-fda-label-change/
Testosterone and Cardiovascular Risk: TRAVERSE Trial and New FDA Label Change
Mohit Khera, MD, MBA, MPH, Professor of Urology, Baylor College of Medicine, discusses evolving understanding of testosterone therapy and cardiovascular risk. In this 13-minute presentation, Dr. Khera focuses on the pivotal TRAVERSE trial and the recent announcement regarding class-wide labeling changes for testosterone products.
History of CV Events and Testosterone Therapy
Dr. Khera traces the history of concern of cardiovascular risks with testosterone therapy. He details that early studies—such as Molly Shores’ 2006 work—showed that low testosterone was associated with higher mortality, particularly due to cardiovascular events. However, between 2010 and 2014, several flawed studies suggested that testosterone therapy could increase cardiovascular risk. These studies prompted the FDA to issue a warning in 2015 restricting labeled indications to men with specific medical conditions, excluding age-related hypogonadism.
The TRAVERSE Trial
The TRAVERSE trial launched out of these concerns. This large, randomized, placebo-controlled trial enrolled over 5,200 men aged 45 to 80 with low testosterone levels and existing cardiovascular risk. Over a mean follow-up of 33 months, the trial found no increase in cardiovascular events among men treated with testosterone compared to placebo. Importantly, no increased risk of prostate cancer or worsening of lower urinary tract symptoms was observed.
TRAVERSE Trial Update in 2025
As a result, in February 2025, the FDA updated the labeling for testosterone products. While maintaining existing restrictions around age-related use, the FDA removed language from the Black Box related to increased risk of cardiovascular outcomes. The FDA now requires inclusion of TRAVERSE results in labeling. Following Ambulatory Blood Pressure Monitoring (ABPM) studies, the FDA requires product-specific information on increased blood pressure for testosterone products with completed ABPM studies. This is in addition to warnings about increased blood pressure across all testosterone products that currently lack such warnings.
Dr. Khera emphasizes the clinical impact of these changes. He notes that previous warnings led many high-risk men to avoid testosterone therapy despite potential benefits. He advocates for further research into the role of testosterone normalization in reducing cardiovascular risk. He also encourages a reevaluation of lingering concerns around prostate health.
ABOUT THE AUTHOR
Mohit Khera, MD, MBA, MPH, is a board-certified urologist specializing in male infertility, male and female sexual dysfunction, and declining testosterone levels in aging men. Dr. Khera’s research focuses on the efficacy of botulinum toxin type A in treating Peyronie’s disease as well as genetic and epigenetic studies on post-finasteride syndrome patients and testosterone-replacement therapy.
Dr. Khera earned his MBA and MPH from Boston University before earning his MD from the University of Texas Medical School at San Antonio. Dr. Khera completed his urology residency training in the Scott Department of Urology at Baylor College of Medicine (BCM) where he also completed a one-year general surgery internship. After completing his urology residency, he went on to complete a one-year fellowship in Male Reproductive Medicine and Surgery at BCM. Currently Dr. Khera is a professor in the Scott Department of Urology at Baylor College of Medicine, and he holds the F. Brantley Scott Chair in urology. Dr. Khera also serves as the director of the Laboratory for Andrology Research, the medical director of the Baylor Executive Health Program and the medical director of the Scott Department of Urology. He also serves as president of the Sexual Medicine Society of North America.
Dr. Khera has initiated numerous FDA-approved clinical trials. His scientific and clinical experiences have allowed him to thus far give over 400 lectures at scientific meetings throughout the world, publish over 160 articles in peer-reviewed journals, complete 15 book chapters, and edit and write two books in the field of sexual medicine and men’s health. Dr. Khera shares his time and knowledge with the general public. He has been voted several times as one of Houston’s Best Doctors by Health and Sport Fitness Magazine and by Houstonia Magazine and is a frequent guest on such TV programs as Fox News’ “Ask theDoctor.” He also writes a blog on men’s health for the Houston Chronicle newspaper.
