TRAVERSE was a multicentre, randomised, double-blind, placebo-controlled noninferiority trial that enrolled 5,246 men aged 45 to 80 with hypogonadism (two morning testosterone readings below 300 ng/dL) plus preexisting cardiovascular disease or high cardiovascular risk. Participants received either daily transdermal 1.62% testosterone gel or placebo gel. The results were published in the New England Journal of Medicine on 16 July 2023 (first presented at ENDO 2023).
Over a mean follow-up of about 33 months, a first major adverse cardiac event (cardiovascular death, nonfatal myocardial infarction or nonfatal stroke) occurred in 182 men (7.0%) on testosterone versus 190 (7.3%) on placebo, a hazard ratio of 0.96 (95% CI 0.78-1.17), meeting the prespecified criterion for noninferiority.
Several secondary safety signals were higher in the testosterone group: atrial fibrillation (3.5% vs 2.4%), acute kidney injury (2.3% vs 1.5%) and pulmonary embolism (0.9% vs 0.5%). The authors noted the atrial fibrillation and acute kidney injury signals had not featured prominently in earlier studies, while the pulmonary embolism finding was consistent with prior data.
The investigators cautioned that the findings apply only to men who meet the clinical indication for treatment and do not justify broad prescribing to aging men without documented hypogonadism.