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 · Has a placebo group

Conditions studied: Hypogonadism, Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT03518034

Run by

AbbVie

People needed

5246

Starts

2018-05-03

Expected to finish

2023-01-19

Last updated by the study team

2024-03-13

Who can join

Age: 45 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Men between 45 and 80 years age
• Participants with low serum testosterone concentrations (< 300 ng/dL) who exhibit at least one sign or symptom of hypogonadism and have evidence of cardiovascular (CV) disease or are at an increased risk for CV disease.

You may not qualify if…

• Participants with congenital or acquired hypogonadism for whom long-term therapy with placebo would not be medically appropriate
• Participants with prostate specific antigen (PSA) > 3.0 ng/mL (or 1.5 if on 5-alpha reductase inhibitors)
• Participants who have been treated with testosterone in the past 6 months and for whom testosterone therapy is contraindicated
• Confirmed testosterone < 100 ng/dL
• Body Mass Index (BMI) > 50
• Hemoglobin A1c (HbA1C) > 11%
• Hematocrit (Hct) > 50%
• Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min
• History of deep vein thrombosis or pulmonary embolism or prostate cancer or heart failure (Class III and IV).

Where it is running

• Simon-Williamson Clinic /ID# 210249 — Birmingham, Alabama, United States
• Alabama Clinical Therapeutics /ID# 202982 — Birmingham, Alabama, United States
• Cahaba Research, Inc. /ID# 167928 — Birmingham, Alabama, United States
• Atlanta VAHCS /ID# 170318 — Decatur, Alabama, United States
• G & L Research, LLC /ID# 170365 — Foley, Alabama, United States
• Fundamental Research /ID# 170504 — Gulf Shores, Alabama, United States
• Urology Centers of Alabama /ID# 206197 — Homewood, Alabama, United States
• Longwood Research /ID# 201754 — Huntsville, Alabama, United States
• Medical Affiliated Research Center, Inc. /ID# 170569 — Huntsville, Alabama, United States
• Mostellar Medical Center /ID# 170329 — Mobile, Alabama, United States
• Terence T. Hart, MD /ID# 201561 — Tuscumbia, Alabama, United States
• Alaska Urological Institute /ID# 167894 — Anchorage, Alaska, United States
• Synexus Clinical Research US, INC /ID# 170530 — Chandler, Arizona, United States
• Fountain Hills Family Practice P.C /ID# 170419 — Fountain Hills, Arizona, United States
• Horizon Clinical Research Asoc /ID# 202937 — Gilbert, Arizona, United States
• Lenzmeier Family Medicine /ID# 202945 — Glendale, Arizona, United States
• Synexus - Desert Clinical Research /ID# 170428 — Mesa, Arizona, United States
• Phoenix Medical Group, PC /ID# 170516 — Peoria, Arizona, United States
• Phoenix VA Health Care System /ID# 167968 — Phoenix, Arizona, United States
• Elite Clinical Studies, LLC /ID# 168058 — Phoenix, Arizona, United States
• Family Practice Specialists /ID# 167859 — Phoenix, Arizona, United States
• Central Phoenix Medical Clinic /ID# 170333 — Phoenix, Arizona, United States
• Tatum Highlands Medical Assoc /ID# 208277 — Phoenix, Arizona, United States
• Fiel Family & Sports Medicine /ID# 203034 — Tempe, Arizona, United States
• Wright Clinical Research, LLC /ID# 210864 — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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