{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T18:31:25Z","timestamp":1787596285041,"version":"build-2736575974"},"reference-count":44,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T00:00:00Z","timestamp":1782777600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"National Institutes of Health & National Cancer Institute"},{"DOI":"10.13039\/100016945","name":"Sidney Kimmel Center for Prostate and Urologic Cancers","doi-asserted-by":"publisher","award":["P30 CA008748"],"award-info":[{"award-number":["P30 CA008748"]}],"id":[{"id":"10.13039\/100016945","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,6,30]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>In recent years, the utilization of testosterone (T)s testing and prescriptions has experienced a significant surge. As a result, the market for testosterone therapy (TTh) has increased dramatically with the surge of T products undergoing trials. Our aim was to undertake a critical analysis of randomized controlled trials (RCTs) that focused on TTh, specifically with an emphasis on the quality of the trials and their delineation of adverse events (AE).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A literature review of PubMed was conducted to identify RCTs using TTh, excluding non-English, animal, or female-based studies. Trials were assessed for sample size, duration, pre-, and post-treatment T levels, adverse event definitions. We also assessed the reported rates of polycythemia (PCT), gynecomastia (GYN), major adverse cardiovascular events (MACE), and obstructive sleep apnea (OSA).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Thirty RCTs met the inclusion criteria, with a median study sample size of 76 and median follow-up of 8\u00a0months. The present analysis reveals that TTh trials are highly heterogeneous in both reporting of definitions and rates of AEs, such as PCT, GYN, and MACE. Among the included trials, 83% measured hematocrit (HCT) levels, but only 23% reported baseline values, with a median baseline HCT of 43% and an on-treatment median of 45%. GYN was reported in 17% of the RCTs, though none detailed the grade of GYN. MACE were reported in only 20% of the trials, with varying definitions. OSA was mentioned as an AE in 33% of trials, but only three reported incidence rates.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>This analysis highlights the suboptimal reporting of AE outcomes in TTh RCTs. These findings underscore the need for a greater level of standardization in such trials.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/sxmrev\/qeag064","type":"journal-article","created":{"date-parts":[[2026,8,9]],"date-time":"2026-08-09T11:32:22Z","timestamp":1786275142000},"source":"Crossref","is-referenced-by-count":0,"title":["A critical analysis of the quality of testosterone therapy randomized controlled trials"],"prefix":"10.1093","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7751-0461","authenticated-orcid":false,"given":"Thiago P","family":"Furtado","sequence":"first","affiliation":[{"name":"Sexual & Reproductive Medicine Program, Urology Service, Memorial Sloan Kettering Cancer Center , New York, NY 10065 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-4382-4810","authenticated-orcid":false,"given":"Luis 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