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
Completed · Phase 4 · NCT03518034
Conditions: Hypogonadism, Cardiovascular Diseases
At a glance
- Research payments reported, 2025
- $116,771
- U.S. investigators named
- 9
- Sites paid
- 9
- Planned or actual enrollment
- 5,246
About the trial
- Sponsor
- AbbVie (with Endo USA Inc., a Keenova Therapeutics Company, Acerus Pharmaceuticals Corporation, Allergan Sales, LLC, Upsher-Smith Laboratories)
- Tested
- AndroGel® (drug), Placebo (drug)
- Dates
- Started 2018-05-03; completion 2023-01-19
- Results posted
- Yes
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.
From ClinicalTrials.gov, last updated 2024-03-13. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $116,771 in research payments for this study in 2025 (25 payments).
Products named: Androgel
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Paul E. Wylie, M.D. Psychiatry · Little Rock, AR
- Thomas C. Fiel, D.O. Sports Medicine · Tempe, AZ
- Ellis R. Levin, M.D. Endocrinology & Diabetes · Long Beach, CA
- Vahid Mahabadi, MD, MPH Endocrinology & Diabetes · Sylmar, CA
- Samuel Penziner Hospitalist · Los Angeles, CA
- Sina Tebi, M.D. Endocrinology & Diabetes · Newhall, CA
- Marcus A. Tellez, DO Family Medicine · Beverly Hills, CA
- Dale C. Allison, MD Family Medicine · Waco, TX
- Veronica G. Fragoso, MD Family Medicine · Houston, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Cognitive Clinical Trials LLC $51,409
- Southern California Institute for Research and Education $28,039
- Preferred Research PArtners Inc $25,551
- Baylor Research Institute $5,456
- Pacific Oaks Medical Group $4,000
- Olive View-UCLA Education $1,000
- Texas Center for Drug Development Inc $994
- Care Access Research $190
- Velocity Clinical Research Inc $132
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.