Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men (TRAVERSE) Study

The TRAVERSE (Testosterone Replacement therapy for Assessmentof long-term Vascular Events and efficacy ResponSE in hypogonadal men) is a Phase 4, randomized, double-blinded, placebo-controlled, multicenter study of topical testosterone replacement therapy (TRT) using an FDA-approved transdermal testosterone preparation (AndroGel®) in symptomatic hypogonadal men between 45 and 80 years of age with increased risk for cardiovascular (CV) disease. The primary endpoint is whether testosterone treatment of men with low testosterone levels and symptoms of hypogonadism at high risk for cardiovascular disease will or will not experience an increased incidence of major adverse cardiovascular events (MACE).