03/04/2025
The FDA determined that testosterone therapy does not increase the risk of heart attack or stroke in men with hypogonadism. This finding came from the TRAVERSE trial, a large clinical trial that included men with a high risk of cardiovascular disease. The incidence of major adverse cardiovascular event (MACE) for subjects receiving AndroGel was 7.0%; for those receiving placebo it was 7.3%. After Agency review, it was determined that the results of TRAVERSE did not demonstrate a new safety signal or trend in adverse cardiovascular outcomes with testosterone use. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/testosterone-information