Phase 4
Completed 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
Source: ClinicalTrials.gov NCT03518034 ↗Enrolled (actual)
5,204
Serious AEs
11.3%
Results posted
Mar 2024
Primary outcomePrimary: 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
◆ Published Evidence
Highly cited
121citations · ~61 / year
Testosterone Treatment and Fractures in Men with Hypogonadism.
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.
Linked Publications (5)
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Testosterone Treatment and Fractures in Men with Hypogonadism.
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Prostate Safety Events During Testosterone Replacement Therapy in Men With Hypogonadism: A Randomized Clinical Trial.
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Efficacy of Testosterone Replacement Therapy in Correcting Anemia in Men With Hypogonadism: A Randomized Clinical Trial.
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Effect of Testosterone on Progression From Prediabetes to Diabetes in Men With Hypogonadism: A Substudy of the TRAVERSE Randomized Clinical Trial.
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Association of testosterone-induced increase in neutrophil and monocyte counts with thromboembolic events: The TRAVERSE trial.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.