6/30/23, 2:20 AM TRAVERSE Pathway Feedback Search Clinical Topics Home Studies TRAVERSE TRAVERSE Disease Male hypogonadism Trial question Is testosterone-replacement therapy noninferior to placebo in men with hypogonadism and preexisting or a high risk of CVD? Study design Multi-center Double blinded RCT Population 5204 male patients Inclusion criteria: men, aged 45-80 years, who had preexisting or a high risk of CVD and who reported symptoms of hypogonadism and had 2 fasting testosterone levels < 300 ng/dL Key exclusion criteria: congenital or acquired severe hypogonadism; history of prostate cancer or prostate nodules; elevated screening PSA level; thrombophilia; uncontrolled HF Interventions N=2601 testosterone (daily transdermal 1.62% gel, dose adjusted to maintain testosterone levels between 350-750 ng/dL) N=2603 placebo (matching placebo gel daily) Primary outcome First occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke 7.3 % 7.3 7 5.5 % 3.6 % 1.8 % https://web.pathway.md/studies/recAIrRuZ5jCOpbXM 1/2 6/30/23, 2:20 AM TRAVERSE Pathway Difference not exceeding nonferiority margin 0.0 % Testosterone Placebo Difference not exceeding nonferiority margin in first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke (7% vs. 7.3%; HR 0.96, 96% CI 0.78 to 1.17) Secondary outcomes No significant difference in first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization (10.4% vs. 10.1%; HR 1.02, 95% CI 0.86 to 1.21) No significant difference in death from cardiovascular causes (3.4% vs. 4%; HR 0.84, 95% CI 0.63 to 1.12) No significant difference in nonfatal myocardial infarction (2.6% vs. 2.4%; HR 1.1, 95% CI 0.78 to 1.56) Safety outcomes No significant differences in adverse and serious adverse event, prostate cancer. Significant differences in nonfatal arrhythmias warranting intervention (5.2% vs. 3.3%), AF (3.5% vs. 2.4%), AKI (2.3% vs. 1.5%). Conclusion In men, aged 45-80 years, who had preexisting or a high risk of CVD and who reported symptoms of hypogonadism and had 2 fasting testosterone levels < 300 ng/dL, testosterone was noninferior to placebo with respect to first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Reference A Michael Lincoff, Shalender Bhasin, Panagiotis Flevaris et al. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023 Jun 16. Open reference URL https://web.pathway.md/studies/recAIrRuZ5jCOpbXM 2/2