Testosterone Replacement therapy for Assessment
of long-term Vascular Events and efficacy ResponSE
in hypogonadal men (TRAVERSE) Study
This is a Phase 4, randomized, double-blind, placebo-controlled, multicenter study of topical TRT in symptomatic hypogonadal men with increased risk for CV disease. The initial planned study enrollment is approximately 6,000 subjects based on the projected timing when 256 MACE (Major Adverse Cardiovascular Events) will occur under initial assumptions of the annual event rate, subject accrual rate, and study discontinuation rate. There will be approximately 400 sites in North America and possibly Puerto Rico. An Interactive Response Technology (IRT) system will randomize subjects to receive either topical testosterone or placebo in a 1:1 ratio. Randomization will be stratified by pre-existing CV disease (Yes/No). Titration of testosterone dose will occur in subjects receiving active testosterone, while sham dosage titrations will occur in subjects receiving placebo gel via the non-blinded central IRT system. The Screening Period is up to 50 days prior to first study drug dose. Once subjects meet all of the eligibility criteria during Screening, they will be randomized (1:1 ratio) to active study drug or placebo and will be followed until the study ends.
Importantly, randomized subjects who elect to discontinue study drug will also be followed until the study ends unless the subject withdraws from the study completely (withdrawal of informed consent) . Subjects who discontinue study drug will still be asked to follow their regularly scheduled protocol visits. Subjects who interrupt study drug will be allowed to restart study drug at any time.