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NCT03518034 · ClinicalTrials.gov registry record · Phase 4
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
A Phase 4 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 4
- Development phase
- 5,246
- Enrollment target
NCT03518034: Completed Phase 4 study, sponsored by AbbVie.
NCT03518034 is a Phase 4 study that has completed, run by AbbVie. The registered enrollment target is 5,246 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (913% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03518034, a Phase 4 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 5,246 participants
- Enrollment target
Study 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.
Primary Outcome
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).
Interventions
- DRUG Placebo
- DRUG AndroGel®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,246 participants |
| Start Date | 2018-05-03 |
| Est. Completion | 2023-01-19 |
| Phase | Phase 4 |
What the finished NCT03518034 record still lists
NCT03518034 is an interventional study that assigns participants to a tested intervention. Its 5,246 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (913% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03518034 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03518034 about?
NCT03518034 is a clinical study titled "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". 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.
What is the current status of trial NCT03518034?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 5,246 participants. The study started on 2018-05-03. Estimated completion is 2023-01-19.
What interventions are being tested in trial NCT03518034?
The interventions under investigation include: Placebo (DRUG), AndroGel® (DRUG).
Who is sponsoring clinical trial NCT03518034?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03518034's enrollment target sits among peer trials
5,246 16th of 2000 higher than 1,985 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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