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NCT01845649 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia
A Phase 3 study, sponsored by Warner Chilcott.
- Completed
- Registry status
- Phase 3
- Development phase
- 550
- Enrollment target
NCT01845649: Completed Phase 3 study, sponsored by Warner Chilcott.
NCT01845649 is a Phase 3 study that has completed, run by Warner Chilcott. The registered enrollment target is 550 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01845649, a Phase 3 study, has completed, sponsored by Warner Chilcott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 550 participants
- Enrollment target
Study Summary
The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant self-assessment when compared to vehicle.
Primary Outcome
Participant's self-assessment of the symptom of VVA (dyspareunia) was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher score indicates the most bothersome symptoms. A negative change from Baseline indicates improvement. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.
Interventions
- DRUG Vehicle
- DRUG WC3011 Estradiol Vaginal Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2013-04-12 |
| Est. Completion | 2013-11-20 |
| Phase | Phase 3 |
What the finished NCT01845649 record still lists
NCT01845649 is an interventional study that assigns participants to a tested intervention. The registered 550 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 (29% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT01845649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01845649 about?
NCT01845649 is a clinical study titled "Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia". The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant self-assessment when compared to vehicle.
What is the current status of trial NCT01845649?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 550 participants. The study started on 2013-04-12. Estimated completion is 2013-11-20.
What interventions are being tested in trial NCT01845649?
The interventions under investigation include: Vehicle (DRUG), WC3011 Estradiol Vaginal Cream (DRUG).
Who is sponsoring clinical trial NCT01845649?
This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01845649's enrollment target sits among peer trials
550 680th of 2000 higher than 1,312 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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