Testosterone and Cardiovascular Risk: The TRAVERSE Trial

How to cite: Köhler TS. “Testosterone and Cardiovascular Risk: The TRAVERSE Trial.” Grand Rounds in Urology. November 13, 2025. Accessed Feb 2026. https://grandroundsinurology.com/testosterone-and-cardiovascular-risk-the-traverse-trial/

Summary

Tobias S. Köhler, MD, MPH, FACS, Professor of Urology, Director of the Andrology Fellowship, Head of Men’s Health, Mayo Clinic, Rochester, Minnesota, reviews the TRAVERSE Trial, a large randomized controlled study designed to evaluate the cardiovascular safety of testosterone therapy in men with symptomatic hypogonadism and elevated cardiovascular risk.

Dr. Köhler explains the background that led to the TRAVERSE Trial. Concerns about cardiovascular risk associated with testosterone therapy arose from observational studies and meta-analyses that produced conflicting results. These concerns prompted regulatory scrutiny and ultimately led the US Food and Drug Administration to require a large, prospective cardiovascular safety trial.

The TRAVERSE Trial enrolled men with symptoms of hypogonadism and confirmed low testosterone levels. Participants were required to have established cardiovascular disease or multiple cardiovascular risk factors. Subjects were randomized to receive either transdermal testosterone gel or a placebo. Testosterone dosing was adjusted to maintain physiologic serum levels rather than supraphysiologic exposure.

The primary endpoint of the study was the occurrence of major adverse cardiovascular events. Participants were followed for a median duration of approximately 33 months. Results demonstrated that testosterone therapy was non-inferior to placebo for the primary cardiovascular endpoint. Dr. Kohler emphasizes that this finding directly addresses the regulatory concern that testosterone therapy increases cardiovascular risk in high-risk men.

Secondary outcomes included prostate-related events, hematologic effects, and other safety signals. No increase in prostate cancer incidence was observed. Rates of acute urinary retention and prostate surgery were similar between groups. Hematocrit increased more frequently in the testosterone group, consistent with known effects of therapy.

Dr. Köhler also discusses less common adverse events that occurred more frequently in the testosterone group, including atrial fibrillation and pulmonary embolism, emphasizing the importance of monitoring. He provides a clear overview of the TRAVERSE Trial and its implications for cardiovascular safety in appropriately selected patients.

About the 32nd Annual Perspectives in Urology: Point Counterpoint conference: Presented by Program Chair and Grand Rounds in Urology Editor-in-Chief E. David Crawford, MD, this conference brought together leading experts in urology, medical oncology, and radiation oncology to discuss and debate the latest topics in genitourinary cancers, primarily prostate cancer and bladder cancer. This interactive conference offered topical lectures, pro/con debates, interesting-case presentations, interactive panel discussions, and interactive audience and faculty networking.