{ "dataset_name": "Long-duration randomized placebo-controlled testosterone treatment trial ledger", "version": "2.0", "last_verified": "2026-09-02", "inclusion_summary": "Randomized, placebo-controlled testosterone assignment; at least 200 men randomized; planned blinded assignment at least six months, with a stated 182-day period counted as six months; completed primary report; each randomized population counted once.", "trial_count": 11, "randomized_total": 9249, "trials": [ { "trial": "TRAVERSE", "publication_year": 2023, "randomized_n": 5246, "blinded_duration": "Median treatment: 21.7 months; median follow-up: 33.0 months", "population": "Men age 45–80 with symptoms, two fasting testosterone results below 300 ng/dL, and existing or high cardiovascular risk", "formulation": "Transdermal 1.62% testosterone gel", "main_question": "Major cardiovascular event safety", "cardiovascular_role": "The only qualifying trial built and powered as a clinical cardiovascular outcomes safety trial", "primary_result": "Primary MACE: 7.0% with testosterone vs 7.3% with placebo; hazard ratio 0.96 (95% CI 0.78–1.17); met the prespecified noninferiority test", "source": "Lincoff et al., 2023", "source_url": "https://doi.org/10.1056/NEJMoa2215025", "registry_id": "NCT03518034" }, { "trial": "T4DM", "publication_year": 2021, "randomized_n": 1007, "blinded_duration": "2 years", "population": "Men age 50–74 with overweight or obesity, low to low-normal testosterone, and impaired glucose tolerance or newly diagnosed type 2 diabetes, all in a lifestyle program", "formulation": "Intramuscular testosterone undecanoate", "main_question": "Prevention or reversal of type 2 diabetes alongside a lifestyle program", "cardiovascular_role": "Not a cardiovascular outcomes trial", "primary_result": "Tested diabetes prevention and metabolic outcomes; cardiovascular events were not the primary end point", "source": "Wittert et al., 2021", "source_url": "https://doi.org/10.1016/S2213-8587(20)30367-3", "registry_id": "ACTRN12612000287831" }, { "trial": "Testosterone Trials (TTrials)", "publication_year": 2016, "randomized_n": 790, "blinded_duration": "1 year", "population": "Men age 65 or older with consistently low testosterone", "formulation": "Transdermal testosterone gel", "main_question": "Sexual function, physical function, vitality, and linked efficacy outcomes", "cardiovascular_role": "The parent trial was not a clinical cardiovascular outcomes trial; a 170-man ancillary study measured coronary plaque", "primary_result": "The ancillary coronary CT study found a greater increase in noncalcified coronary plaque volume with testosterone, but it did not test heart attacks or strokes", "source": "Snyder et al., 2016; Budoff et al., 2017", "source_url": "https://doi.org/10.1056/NEJMoa1506119", "secondary_source_url": "https://doi.org/10.1001/jama.2016.21043", "registry_id": "NCT00799617" }, { "trial": "Behre et al.", "publication_year": 2012, "randomized_n": 362, "blinded_duration": "6 months", "population": "Men with hypogonadism", "formulation": "Transdermal 2% testosterone gel", "main_question": "Dose, testosterone normalization, efficacy, and safety", "cardiovascular_role": "Not a cardiovascular outcomes trial", "primary_result": "A product efficacy and safety trial; it was not designed to settle heart-attack or stroke risk", "source": "Behre et al., 2012", "source_url": "https://doi.org/10.1016/j.eururo.2011.12.016", "registry_id": "" }, { "trial": "Legros et al.", "publication_year": 2009, "randomized_n": 322, "blinded_duration": "12 months", "population": "Symptomatic older men with late-onset hypogonadism eligibility", "formulation": "Oral testosterone undecanoate", "main_question": "Symptoms and sexual function across oral doses", "cardiovascular_role": "Not a cardiovascular outcomes trial", "primary_result": "A symptom and dose-response trial; it was not designed to settle clinical cardiovascular risk", "source": "Legros et al., 2009", "source_url": "https://doi.org/10.1530/EJE-08-0884", "registry_id": "" }, { "trial": "TEAAM", "publication_year": 2015, "randomized_n": 308, "blinded_duration": "3 years", "population": "Men age 60 or older with low or low-normal testosterone", "formulation": "Transdermal testosterone gel", "main_question": "Carotid artery wall thickness and coronary artery calcium", "cardiovascular_role": "A cardiovascular imaging trial, not a clinical event trial", "primary_result": "No significant between-group difference in the prespecified atherosclerosis imaging progression measures", "source": "Basaria et al., 2015", "source_url": "https://doi.org/10.1001/jama.2015.8881", "registry_id": "NCT00287586" }, { "trial": "Kaufman et al.", "publication_year": 2011, "randomized_n": 274, "blinded_duration": "182 days", "population": "Men with hypogonadism", "formulation": "Transdermal 1.62% testosterone gel", "main_question": "Testosterone normalization, efficacy, and safety", "cardiovascular_role": "Not a cardiovascular outcomes trial", "primary_result": "A product efficacy and safety trial; it was not designed to settle heart-attack or stroke risk", "source": "Kaufman et al., 2011", "source_url": "https://doi.org/10.1111/j.1743-6109.2011.02279.x", "registry_id": "" }, { "trial": "Srinivas-Shankar et al.", "publication_year": 2010, "randomized_n": 274, "blinded_duration": "6 months", "population": "Intermediate-frail and frail older men with low testosterone", "formulation": "Transdermal testosterone gel", "main_question": "Muscle strength, physical function, body composition, and quality of life", "cardiovascular_role": "Not a cardiovascular outcomes trial", "primary_result": "A function and frailty trial; cardiovascular events were not the primary end point", "source": "Srinivas-Shankar et al., 2010", "source_url": "https://doi.org/10.1210/jc.2009-1251", "registry_id": "" }, { "trial": "Emmelot-Vonk et al.", "publication_year": 2008, "randomized_n": 237, "blinded_duration": "6 months", "population": "Men age 60–80 with low testosterone", "formulation": "Oral testosterone undecanoate", "main_question": "Functional mobility, cognition, body composition, metabolic measures, and quality of life", "cardiovascular_role": "Not a cardiovascular outcomes trial", "primary_result": "A broad aging and function trial; it was not designed to settle clinical cardiovascular risk", "source": "Emmelot-Vonk et al., 2008", "source_url": "https://pubmed.ncbi.nlm.nih.gov/18167405/", "registry_id": "" }, { "trial": "TIMES2", "publication_year": 2011, "randomized_n": 220, "blinded_duration": "12 months", "population": "Hypogonadal men with type 2 diabetes, metabolic syndrome, or both", "formulation": "Transdermal 2% testosterone gel", "main_question": "Insulin resistance and metabolic control", "cardiovascular_role": "Not a cardiovascular outcomes trial", "primary_result": "A metabolic trial; clinical cardiovascular events were not the primary end point", "source": "Jones et al., 2011", "source_url": "https://doi.org/10.2337/dc10-1233", "registry_id": "NCT00399412" }, { "trial": "TOM", "publication_year": 2010, "randomized_n": 209, "blinded_duration": "6 months planned; trial stopped early", "population": "Men age 65 or older with low testosterone and mobility limits", "formulation": "Transdermal testosterone gel", "main_question": "Muscle strength and physical function", "cardiovascular_role": "Not powered as a cardiovascular outcomes trial; stopped early after a cardiovascular adverse-event imbalance", "primary_result": "Cardiovascular-related adverse events were reported in 23 testosterone participants and 5 placebo participants; the event category was broader than MACE", "source": "Basaria et al., 2010", "source_url": "https://doi.org/10.1056/NEJMoa1000485", "registry_id": "NCT00240981" } ] }