A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men

Summary

This is a double-blinded and placebo-controlled study of topical testosterone replacement therapy (TRT) in symptomatic hypogonadal men with pre-existing cardiovascular disease (CVD) or increased risk for CVD.

Timeline

Start

2018-05-03

Primary completion

2023-01-19

Completion

2023-01-19

Publications

• Gagliano-Juca T, Pencina KM, Shang YV, Travison TG, Lincoff AM, Nissen SE, Artz AS, Li X, Chan A, Patel R, Miller MG, Bhasin S. Association of testosterone-induced increase in neutrophil and monocyte counts with thromboembolic events: The TRAVERSE trial. Am Heart J. 2025 Oct;288:77-88. doi: 10.1016/j.ahj.2025.04.004. Epub 2025 Apr 15.
• Bhasin S, Lincoff AM, Nissen SE, Wannemuehler K, McDonnell ME, Peters AL, Khan N, Snabes MC, Li X, Li G, Buhr K, Pencina KM, Travison TG. Effect of Testosterone on Progression From Prediabetes to Diabetes in Men With Hypogonadism: A Substudy of the TRAVERSE Randomized Clinical Trial. JAMA Intern Med. 2024 Apr 1;184(4):353-362. doi: 10.1001/jamainternmed.2023.7862.
• Snyder PJ, Bauer DC, Ellenberg SS, Cauley JA, Buhr KA, Bhasin S, Miller MG, Khan NS, Li X, Nissen SE. Testosterone Treatment and Fractures in Men with Hypogonadism. N Engl J Med. 2024 Jan 18;390(3):203-211. doi: 10.1056/NEJMoa2308836.
• Bhasin S, Travison TG, Pencina KM, O'Leary M, Cunningham GR, Lincoff AM, Nissen SE, Lucia MS, Preston MA, Khera M, Khan N, Snabes MC, Li X, Tangen CM, Buhr KA, Thompson IM Jr. Prostate Safety Events During Testosterone Replacement Therapy in Men With Hypogonadism: A Randomized Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2348692. doi: 10.1001/jamanetworkopen.2023.48692.
• Pencina KM, Travison TG, Artz AS, Lincoff AM, Nissen SE, Flevaris P, Chan A, Li X, Diegel SA, Wannemuehler K, Bhasin S. Efficacy of Testosterone Replacement Therapy in Correcting Anemia in Men With Hypogonadism: A Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2340030. doi: 10.1001/jamanetworkopen.2023.40030.
• Lincoff AM, Bhasin S, Flevaris P, Mitchell LM, Basaria S, Boden WE, Cunningham GR, Granger CB, Khera M, Thompson IM Jr, Wang Q, Wolski K, Davey D, Kalahasti V, Khan N, Miller MG, Snabes MC, Chan A, Dubcenco E, Li X, Yi T, Huang B, Pencina KM, Travison TG, Nissen SE; TRAVERSE Study Investigators. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023 Jul 13;389(2):107-117. doi: 10.1056/NEJMoa2215025. Epub 2023 Jun 16.

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Indications