Martin M. Miner, MD, outlines data on testosterone therapy

At the 2025 LUGPA Annual Meeting, Martin M. Miner, MD, delivered a talk titled, “Testosterone Controversies: Lessons Learned from TRAVERSE 2025.” In an interview with Urology Times®, Miner outlined recent data on testosterone therapy, including findings from TRAVERSE (NCT03518034)and the T4DM study. Miner also described the impact that these studies have had on conversations surrounding the safety and efficacy of testosterone.

Miner is the co-director of the men’s health center at Brown University Health in Providence, Rhode Island.

Miner began by outlining key findings from the TRAVERSE trial,¹ which led to a label revision for testosterone products in March 2025. In total, the study enrolled and randomly assigned 5204 men to transdermal 1.62% testosterone gel (n = 2601) or placebo gel (n = 2603).

Overall, a cardiovascular event (the first adjudicated major adverse cardiac event) was reported in 7.0% (182) patients in the testosterone arm vs 7.3% (190) in the placebo arm (HR, 0.96; 95% CI, 0.78 to 1.17; P < .001 for noninferiority). The investigators also observed “no clinically meaningful difference” between the 2 cohorts in the incidence of a secondary cardiovascular end point, which was defined as “the first occurrence of any component of the composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization.”

Miner also briefly touched on findings from the phase 3b T4DM study, which found that the rate of type 2 diabetes was improved in the group that received testosterone therapy for 2 years (relative risk, 0.59, 95% CI, 0.43 to 0.80; P = .0007). Specifically, 21% of patients in the placebo group vs 12% of patients in the testosterone group had 2-h glucose of 11.1 mmol/L or higher on oral glucose tolerance test at 2 years.

REFERENCES

1. Lincoff AM, Bhasin S, Flevaris P, et al. Cardiovascular safety of testosterone-replacement therapy. N Engl J Med. 2023;389(2):107-117. doi:10.1056/NEJMoa2215025

2. Wittert G, Bracken K, Robledo KP, et al. Testosterone treatment to prevent or revert type 2 diabetes in men enrolled in a lifestyle programme (T4DM): a randomised, double-blind, placebo-controlled, 2-year, phase 3b trial. Lancet Diabetes Endocrinol. 2021;9(1):32-45. doi:10.1016/S2213-8587(20)30367-3