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NCT01400776 · ClinicalTrials.gov registry record · Phase 3
Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women
A Phase 3 study of Postmenopausal Vulvovaginal Atrophy, sponsored by Warner Chilcott.
- Completed
- Registry status
- Phase 3
- Development phase
- 722
- Enrollment target
- 20
- Study locations
NCT01400776: Completed Phase 3 study of Postmenopausal Vulvovaginal Atrophy, sponsored by Warner Chilcott.
NCT01400776 is a Phase 3 study of Postmenopausal Vulvovaginal Atrophy that has completed, run by Warner Chilcott. The registered enrollment target is 722 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01400776, a Phase 3 study of Postmenopausal Vulvovaginal Atrophy, has completed, sponsored by Warner Chilcott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 722 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.
Primary Outcome
The severity of vaginal dryness was assessed and recorded on a questionnaire by the participants using the following 4 point scale where, 0=None (The symptom is not present), 1=Mild (The symptom is present but may be intermittent; does not interfere with participants activities or lifestyle), 2=Moderate (The symptom is present. Participant is usually aware of the symptom, but activities and lifestyle are only occasionally affected), and 3=Severe (The symptom is present. Participant is usually aw
Conditions Studied
Interventions
- DRUG Vehicle
- DRUG WC3011 Estradiol Vaginal Cream
Study Locations (20)
Florida
- Visions Clinical Research - Boynton Beach
- Women's Medical Research Group, LLC - Clearwater
- Jacksonville Center for Clinical Research - Jacksonville
- Miami Research Associates - Miami
- New Age Medical Research Corp - Miami
- Ormond Medical Arts Pharmaceutical Research Center - Ormond Beach
- OB-GYN Specialists of the Palm - Palm Beach Gardens
- Radiant Research-St. Petersburg - Pinellas Park
Arizona
- Women's Health Research - Phoenix
- Precision Trials, LLC - Phoenix
- Radiant Research-Scottsdale - Scottsdale
- Radiant Research-Tucson - Tucson
- Visions Clinical Research-tucson - Tucson
California
- Genesis Center for Clinical Research - San Diego
- Medical Center for Clinical Research - San Diego
- Women's Healthcare Inc. - San Diego
Alabama
- Medical Affiliated Research Center, Inc. - Huntsville
- Mobile OB-GYN, PC - Mobile
Colorado
- Physicians' Research Options LLC - Lakewood
Connecticut
- Costal Connecticut Resarch, LLC - New London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 722 participants |
| Start Date | 2011-06-29 |
| Est. Completion | 2012-02-27 |
| Phase | Phase 3 |
What the finished NCT01400776 record still lists
NCT01400776 is an interventional study that assigns participants to a tested intervention. The registered 722 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 1 condition, with Postmenopausal Vulvovaginal Atrophy appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.
NCT01400776 names 20 study sites across 6 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT01400776 about?
NCT01400776 is a clinical study titled "Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women". Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.
What is the current status of trial NCT01400776?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 722 participants. The study started on 2011-06-29. Estimated completion is 2012-02-27.
What conditions does trial NCT01400776 study?
This clinical trial studies the following conditions: Postmenopausal Vulvovaginal Atrophy.
What interventions are being tested in trial NCT01400776?
The interventions under investigation include: Vehicle (DRUG), WC3011 Estradiol Vaginal Cream (DRUG).
Who is sponsoring clinical trial NCT01400776?
This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01400776 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
How this trial's enrollment target compares
Where NCT01400776's enrollment target sits among peer trials
722 494th of 2000 higher than 1,507 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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