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NCT00809471 · ClinicalTrials.gov registry record · Phase 3
Research Evaluating an Investigational Medication for Erectile Dysfunction - Diabetic ED (REVIVE-D)
A Phase 3 study, sponsored by VIVUS.
- Completed
- Registry status
- Phase 3
- Development phase
- 390
- Enrollment target
NCT00809471: Completed Phase 3 study, sponsored by VIVUS.
NCT00809471 is a Phase 3 study that has completed, run by VIVUS. The registered enrollment target is 390 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00809471, a Phase 3 study, has completed, sponsored by VIVUS.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 390 participants
- Enrollment target
Study Summary
This study is being conducted to compare the safety and efficacy of 2 doses of avanafil to placebo in diabetic men with mild to severe erectile dysfunction.
Primary Outcome
Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 "Did your erection last long enough for you to have successful intercourse?"
Interventions
- DRUG placebo
- DRUG avanafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2008-12 |
| Est. Completion | 2010-02 |
| Phase | Phase 3 |
What the finished NCT00809471 record still lists
NCT00809471 is an interventional study that assigns participants to a tested intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00809471 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00809471 about?
NCT00809471 is a clinical study titled "Research Evaluating an Investigational Medication for Erectile Dysfunction - Diabetic ED (REVIVE-D)". This study is being conducted to compare the safety and efficacy of 2 doses of avanafil to placebo in diabetic men with mild to severe erectile dysfunction.
What is the current status of trial NCT00809471?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 390 participants. The study started on 2008-12. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00809471?
The interventions under investigation include: placebo (DRUG), avanafil (DRUG).
Who is sponsoring clinical trial NCT00809471?
This trial is sponsored by VIVUS, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00809471's enrollment target sits among peer trials
390 968th of 2000 higher than 1,029 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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