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
- Conditions
- HypogonadismCardiovascular Diseases
- Interventions
- Drug: Placebo
- Registration Number
- NCT03518034
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 5246
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AndroGel 1.62% AndroGel® Participants receive topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug once daily (OD). Participants may receive a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations are necessary. Placebo Placebo Participants receive matching placebo OD.
- Primary Outcome Measures
Name Time Method Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event Randomization to event or last known date if no event (up to approximately 52 months) MACE is a composite endpoint including non-fatal myocardial infraction (MI), non-fatal stroke and cardiovascular (CV) death as adjudicated by Clinical Events Committee (CEC).
Time From Randomization to the First Component Event of MACE Randomization to event or last known date if no event (up to approximately 52 months) MACE is a composite endpoint including non-fatal MI, non-fatal stroke and CV death as adjudicated by CEC.
- Secondary Outcome Measures
Name Time Method Incidence of High-Grade Prostate Cancer Randomization to event or last known date if no event (up to approximately 52 months). Presented as the number and percentage of participants with any high grade prostate cancer, defined as Gleason grade of 4 + 3 or higher, as adjudicated by Prostate Safety Events Committee (PAC). This grade is based on how abnormal prostate cells appear. Grade 1: cells look almost like normal prostate cells; Grade 5; cells look very different from normal prostate cells. Since most prostate cancers contain cells of different grades, the 2 most common grades are used. Gleason score is determined by adding the 2 most common grades. Higher numbers indicate a faster growing cancer that is more likely to spread. Currently the lowest score assigned to a tumor is grade 3. Grades below 3 show normal to near normal cells. Most cancers have a Gleason score (the sum of the 2 most common grades) of 6 (Gleason scores of 3+3) or 7 (Gleason scores of 3+4 or 4+3).
Time From Randomization to the First Component Event of CV Safety Endpoint: Number and Percentage of Participants With an Event Randomization to event or last known date if no event (up to approximately 52 months). The CV safety endpoint is a composite endpoint including non-fatal MI, non-fatal stroke, CV death, and coronary revascularization procedures/cardiac percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG) as adjudicated by CEC.
Time From Randomization to the First Component Event of CV Safety Endpoint Randomization to event or last known date if no event (up to approximately 52 months). The CV safety endpoint is a composite endpoint including non-fatal MI, non-fatal stroke, CV death, and coronary revascularization procedures/cardiac PCI, or CABG as adjudicated by CEC.
Trial Locations
- Locations (384)
Wright Clinical Research, LLC /ID# 210864
🇺🇸Alabaster, Alabama, United States
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
Scroll for more (374 remaining)Wright Clinical Research, LLC /ID# 210864🇺🇸Alabaster, Alabama, United States