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NCT01037244 · ClinicalTrials.gov registry record · Phase 3
Treatment of Erectile Dysfunction I
A Phase 3 study of Erectile Dysfunction, sponsored by Warner Chilcott.
- Completed
- Registry status
- Phase 3
- Development phase
- 618
- Enrollment target
- 20
- Study locations
NCT01037244: Completed Phase 3 study of Erectile Dysfunction, sponsored by Warner Chilcott.
NCT01037244 is a Phase 3 study of Erectile Dysfunction that has completed, run by Warner Chilcott. The registered enrollment target is 618 participants, above the 213-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (190% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01037244, a Phase 3 study of Erectile Dysfunction, has completed, sponsored by Warner Chilcott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 618 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 (poor) - 5/(good) scoring scale for each of 6 questions (0-30/max/good). Over last month: How often were you able to get an erection during sex? 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 o
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Udenafil
Study Locations (20)
California
- Warner Chilcott Investigational Site - Laguna Hills
- Warner Chilcott Investigational Site - Newport Beach
- Warner Chilcott Investigational Site - San Diego
- Warner Chilcott Investigational Site - Torrance
Arizona
- Warner Chilcott Investigational Site - Mesa
- Warner Chilcott Investigational Site - Phoenix
- Warner Chilcott Investigational Site - Tucson
Connecticut
- Warner Chilcott Investigational Site - Middlebury
- Warner Chilcott Investigational Site - New Britain
- Warner Chilcott Investigational Site - Waterbury
Florida
- Warner Chilcott Investigational Site - Clearwater
- Warner Chilcott Investigational Site - Miami
- Warner Chilcott Investigational Site - Ocala
Alabama
- Warner Chilcott Investigational Site - Birmingham
- Warner Chilcott Investigational Site - Homewood
Colorado
- Warner Chilcott Investigational Site - Denver
Georgia
- Warner Chilcott Investigational Site - Columbus
Illinois
- Warner Chilcott Investigational Site - Melrose Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 618 participants |
| Start Date | 2009-09 |
| Est. Completion | 2010-03 |
| Phase | Phase 3 |
What the finished NCT01037244 record still lists
NCT01037244 is an interventional study that assigns participants to a tested intervention. The registered 618 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 (190% 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.
NCT01037244 names 20 study sites across 10 states, led by California, Arizona, Connecticut.
Frequently Asked Questions
What is clinical trial NCT01037244 about?
NCT01037244 is a clinical study titled "Treatment of Erectile Dysfunction I". 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 NCT01037244?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 618 participants. The study started on 2009-09. Estimated completion is 2010-03.
What conditions does trial NCT01037244 study?
This clinical trial studies the following conditions: Erectile Dysfunction.
What interventions are being tested in trial NCT01037244?
The interventions under investigation include: Placebo (DRUG), Udenafil (DRUG).
Who is sponsoring clinical trial NCT01037244?
This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01037244 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 NCT01037244's enrollment target sits among peer trials
618 4th of 33 higher than 30 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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