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NCT00655629 · ClinicalTrials.gov registry record · Phase 3
Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 339
- Enrollment target
NCT00655629: Completed Phase 3 study, sponsored by Bayer.
NCT00655629 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 339 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00655629, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 339 participants
- Enrollment target
Study Summary
This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.
Primary Outcome
The primary variable was the treatment group difference from baseline to Week 12 or LOCF of the least square mean difference in the IIEF-EF domain score (Range: 1-30 ordinal. Directionality: severity of erectile dysfunction: \<=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; \>25 'no ED'.)
Interventions
- DRUG Placebo
- DRUG Vardenafil ODT (STAXYN, BAY38-9456)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 339 participants |
| Start Date | 2008-04 |
| Est. Completion | 2009-02 |
| Phase | Phase 3 |
What the finished NCT00655629 record still lists
NCT00655629 is an interventional study that assigns participants to a tested intervention. The registered 339 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 (56% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00655629 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00655629 about?
NCT00655629 is a clinical study titled "Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.". This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil O...
What is the current status of trial NCT00655629?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 339 participants. The study started on 2008-04. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00655629?
The interventions under investigation include: Placebo (DRUG), Vardenafil ODT (STAXYN, BAY38-9456) (DRUG).
Who is sponsoring clinical trial NCT00655629?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00655629's enrollment target sits among peer trials
339 1056th of 2000 higher than 944 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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