Phase 4
N=5,204
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
Hypogonadism · Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03518034 ↗Enrolled (actual)
5,204
Serious AEs
11.3%
Results posted
Mar 2024
Primary outcome: Primary: Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event — 182; 190 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- AndroGel® (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Male
- Sponsor
- AbbVie
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event |
182; 190 | — |
| PRIMARY Time From Randomization to the First Component Event of MACE |
NA; NA | — |
| SECONDARY Time From Randomization to the First Component Event of CV Safety Endpoint: Number and Percentage of Participants With an Event |
269; 264 | — |
| SECONDARY Time From Randomization to the First Component Event of CV Safety Endpoint |
NA; NA | — |
| SECONDARY Incidence of High-Grade Prostate Cancer |
5; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Men between 45 and 80 years age
- Participants with low serum testosterone concentrations ( 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 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).
Data sourced from ClinicalTrials.gov (NCT03518034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.