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NCT01037218 · ClinicalTrials.gov registry record · Phase 3
Treatment of Erectile Dysfunction II
A Phase 3 study of Erectile Dysfunction, sponsored by Warner Chilcott.
- Completed
- Registry status
- Phase 3
- Development phase
- 601
- Enrollment target
- 20
- Study locations
NCT01037218: Completed Phase 3 study of Erectile Dysfunction, sponsored by Warner Chilcott.
NCT01037218 is a Phase 3 study of Erectile Dysfunction that has completed, run by Warner Chilcott. The registered enrollment target is 601 participants, above the 213-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (182% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01037218, a Phase 3 study of Erectile Dysfunction, has completed, sponsored by Warner Chilcott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 601 participants
- Enrollment target
- 20
- Study locations
Study Summary
Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).
Primary Outcome
Erectile Function domain: 0 - 5 scoring scale for each of 6 questions (scale: 0/min/poor - 30/max/good). Over last month: How often were you able to get erection? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercou
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Udenafil
Study Locations (20)
Florida
- Warner Chilcott Investigational Site - Aventura
- Warner Chilcott Investigational Site - Daytona Beach
- Warner Chilcott Investigational Site - DeLand
- Warner Chilcott Investigational Site - Ocala
- Warner Chilcott Investigational Site - Tampa
Alabama
- Warner Chilcott Investigational Site - Birmingham
- Warner Chilcott Investigational Site - Huntsville
California
- Warner Chilcott Investigational Site - Chino
- Warner Chilcott Investigational Site - Tarzana
Georgia
- Warner Chilcott Investigational Site - Dawsonville
- Warner Chilcott Investigational Site - Sandy Springs
Indiana
- Warner Chilcott Investigational Site - Fort Wayne
- Warner Chilcott Investigational Site - Greenwood
Maryland
- Warner Chilcott Investigational Site - Elkridge
- Warner Chilcott Investigational Site - Greenbelt
Arizona
- Warner Chilcott Investigational Site - Tempe
Colorado
- Warner Chilcott Investigational Site - Englewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 601 participants |
| Start Date | 2009-09 |
| Est. Completion | 2010-04 |
| Phase | Phase 3 |
What the finished NCT01037218 record still lists
NCT01037218 is an interventional study that assigns participants to a tested intervention. The registered 601 participants enrollment target is mid-sized for trials with a published cap, above the 213-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (182% higher).
The record links to 1 condition, with Erectile Dysfunction appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01037218 names 20 study sites across 11 states, led by Florida, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT01037218 about?
NCT01037218 is a clinical study titled "Treatment of Erectile Dysfunction II". Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).
What is the current status of trial NCT01037218?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 601 participants. The study started on 2009-09. Estimated completion is 2010-04.
What conditions does trial NCT01037218 study?
This clinical trial studies the following conditions: Erectile Dysfunction.
What interventions are being tested in trial NCT01037218?
The interventions under investigation include: Placebo (DRUG), Udenafil (DRUG).
Who is sponsoring clinical trial NCT01037218?
This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01037218 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Erectile Dysfunction
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01037218's enrollment target sits among peer trials
601 5th of 33 higher than 29 of 33 other Erectile Dysfunction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Erectile Dysfunction 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.
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