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NCT01455597 · ClinicalTrials.gov registry record · Phase 3
Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)
A Phase 3 study of Vulvovaginal Atrophy, sponsored by Warner Chilcott.
- Completed
- Registry status
- Phase 3
- Development phase
- 309
- Enrollment target
- 20
- Study locations
NCT01455597: Completed Phase 3 study of Vulvovaginal Atrophy, sponsored by Warner Chilcott.
NCT01455597 is a Phase 3 study of Vulvovaginal Atrophy that has completed, run by Warner Chilcott. The registered enrollment target is 309 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01455597, a Phase 3 study of Vulvovaginal Atrophy, has completed, sponsored by Warner Chilcott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 309 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label extension study evaluating the long-term safety and efficacy of WC3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.
Primary Outcome
The endometrial biopsy results was categorized as: normal results categorized as atrophic/inactive or proliferative, unsatisfactory with endometrial thickness ≤4 mm and missing biopsy with endometrial thickness ≤4 mm; abnormal results categorized as polyp, hyperplasia, and carcinoma; unknown result categorized as unsatisfactory with endometrial thickness \>4 mm, missing biopsy with endometrial thickness \>4 mm, unsatisfactory without transvaginal ultrasonography (TVU) result and missing biopsy w
Conditions Studied
Interventions
- 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 Beaches - Palm Beach Gardens
- Radiant Research-St. Petersburg - Pinellas Park
- Comprehensive Clinical Trials, LLC - West Palm Beach
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
- Warner Chilcott Investigational Site - Mobile
Connecticut
- Coastal Connecticut Research, LLC - New London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 309 participants |
| Start Date | 2011-10-20 |
| Est. Completion | 2012-12-03 |
| Phase | Phase 3 |
What the finished NCT01455597 record still lists
NCT01455597 is an interventional study that assigns participants to a tested intervention. The registered 309 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 (60% lower).
The record links to 1 condition, with Vulvovaginal Atrophy appearing as the primary indexed condition, and to 1 intervention - of which WC3011 Estradiol Vaginal Cream is the first listed.
NCT01455597 names 20 study sites across 5 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT01455597 about?
NCT01455597 is a clinical study titled "Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)". This is an open-label extension study evaluating the long-term safety and efficacy of WC3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.
What is the current status of trial NCT01455597?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 309 participants. The study started on 2011-10-20. Estimated completion is 2012-12-03.
What conditions does trial NCT01455597 study?
This clinical trial studies the following conditions: Vulvovaginal Atrophy.
What interventions are being tested in trial NCT01455597?
The interventions under investigation include: WC3011 Estradiol Vaginal Cream (DRUG).
Who is sponsoring clinical trial NCT01455597?
This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01455597 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01455597's enrollment target sits among peer trials
309 1109th of 2000 higher than 889 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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