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NCT00413244 · ClinicalTrials.gov registry record · Phase 3
The Cardiac Benefit of Testosterone Replacement in Men With Low Testosterone Levels With Coronary Artery Disease After Successful Intervention of the Blockage or Narrowed Heart Artery
A Phase 3 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 3
- Development phase
- 51
- Enrollment target
NCT00413244: Completed Phase 3 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT00413244 is a Phase 3 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 51 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00413244, a Phase 3 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 51 participants
- Enrollment target
Study Summary
The purpose of the study is to find out if giving the study drug, Androgel (testosterone) as a testosterone replacement help bring the testosterone to an acceptable level and to find out if it will help improve heart condition in males with coronary artery disease (CAD) following successful percutaneous coronary intervention.
Primary Outcome
Treadmill exercise testing performed according to the Bruce protocol (MAX-1 Marquette advanced exercise system, software version 002E). The system analyzed the signal averaged ECG and produces a graphical display of the level of the ST segment 80 ms after the J point against time. Time to 1 mm ST depression was measured from computer derived analysis, effectively eliminating observer bias.
Interventions
- DRUG Placebo
- DRUG AndroGel 5 Grams
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2007-01 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
What the finished NCT00413244 record still lists
NCT00413244 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00413244 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00413244 about?
NCT00413244 is a clinical study titled "The Cardiac Benefit of Testosterone Replacement in Men With Low Testosterone Levels With Coronary Artery Disease After Successful Intervention of the Blockage or Narrowed Heart Artery". The purpose of the study is to find out if giving the study drug, Androgel (testosterone) as a testosterone replacement help bring the testosterone to an acceptable level and to find out if it will help improve heart condition in males with coronary artery disease (CAD) following successful percutan...
What is the current status of trial NCT00413244?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2007-01. Estimated completion is 2014-11.
What interventions are being tested in trial NCT00413244?
The interventions under investigation include: Placebo (DRUG), AndroGel 5 Grams (DRUG).
Who is sponsoring clinical trial NCT00413244?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00413244's enrollment target sits among peer trials
51 1842nd of 2000 higher than 157 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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