The largest randomized controlled trial ever conducted on testosterone replacement therapy enrolled 5,246 men across 316 clinical sites in the United States. Researchers found no significant difference in rates of heart attack, stroke, or cardiovascular death between men receiving TRT and those receiving placebo over a mean follow-up period of 33 months. The study was commissioned by the FDA and independently analyzed by the Cleveland Clinic.

These findings directly informed the FDA's 2025 decision to remove the longstanding cardiovascular warning label from testosterone products.

Lincoff et al. | New England Journal of Medicine | Vol. 389, No. 2 | July 2023 | TRAVERSE Study Investigators

Read the full journal: https://www.nejm.org/doi/10.1056/NEJMoa2215025?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed