6/30/23, 2:22 AM Testosterone Trial Pathway Feedback Search Clinical Topics Home Studies Testosterone Trial Testosterone Trial Disease Disease Male hypogonadism Testosterone deficiency Trial question What is the role of testosterone treatment in older men? Study design Multi-center Double blinded RCT Population 790 male patients Inclusion criteria: men 65 years of age with serum testosterone concentration of < 275 ng/dL and symptoms suggesting hypoandrogenism Key exclusion criteria: history of prostate cancer, a risk of all prostate cancer of > 35% or of high- grade prostate cancer of > 7% as determined according to the Prostate Cancer Risk Calculator, an IPSS (IPSS; range, 0-35, with higher scores indicating more severe symptoms of benign prostatic hyperplasia) of > 19, conditions known to cause hypogonadism, receipt of medications that alter the testosterone concentration, or high cardiovascular risk Interventions N=395 testosterone gel (AndroGel 1% with an initial dose of 5 g daily) N=395 placebo (similar application and appearance to AndroGel) Primary outcome Percentage of patients achieving an improvement of at least 50 m in 6-minute walking distance 20.3 % 20.3 15.2 % 12.1 10.2 % https://web.pathway.md/studies/rechzmUYmfxEcPmhC 1/2 6/30/23, 2:22 AM Testosterone Trial Pathway 5.1 % No significant difference 0.0 % Testosterone gel Placebo No significant difference in the percentage of patients achieving an improvement of at least 50 m in 6MWD (20.3% vs. 12.1%; OR 1.42, 95% CI 0.83 to 2.45) Secondary outcomes No significant difference in the percentage of patients achieving an improvement of least 4 points on the Functional Assessment of Chronic Illness Therapy-Fatigue scale (72.4% vs. 62.8%; OR 1.23, 95% CI 0.83 to 1.84) Safety outcomes No significant difference in rates of adverse events. Conclusion In men 65 years of age with serum testosterone concentration of < 275 ng/dL and symptoms suggesting hypoandrogenism, testosterone gel was superior to placebo with respect to the percentage of patients achieving an improvement of at least 50 m in 6MWD. Reference Snyder PJ, Bhasin S, Cunningham GR et al. Effects of Testosterone Treatment in Older Men. N Engl J Med. 2016 Feb 18;374(7):611-24. Open reference URL https://web.pathway.md/studies/rechzmUYmfxEcPmhC 2/2