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NCT01816139 · ClinicalTrials.gov registry record · Phase 3
Multicenter Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women
A Phase 3 study, sponsored by Warner Chilcott.
- Completed
- Registry status
- Phase 3
- Development phase
- 576
- Enrollment target
NCT01816139: Completed Phase 3 study, sponsored by Warner Chilcott.
NCT01816139 is a Phase 3 study that has completed, run by Warner Chilcott. The registered enrollment target is 576 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01816139, a Phase 3 study, has completed, sponsored by Warner Chilcott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 576 participants
- Enrollment target
Study Summary
The primary objective of this study is to compare the efficacy of WC3011 with placebo vaginal gel in postmenopausal women for the relief of vaginal dryness caused by vaginal atrophy as measured by self-assessment, vaginal pH and vaginal smear.
Primary Outcome
Participant's self-assessment of Vaginal Dryness was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores indicate the most bothersome symptoms. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.
Interventions
- DRUG Vehicle
- DRUG WC3011 Estradiol Vaginal Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 576 participants |
| Start Date | 2013-01-31 |
| Est. Completion | 2013-11-19 |
| Phase | Phase 3 |
What the finished NCT01816139 record still lists
NCT01816139 is an interventional study that assigns participants to a tested intervention. The registered 576 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 (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT01816139 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01816139 about?
NCT01816139 is a clinical study titled "Multicenter Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women". The primary objective of this study is to compare the efficacy of WC3011 with placebo vaginal gel in postmenopausal women for the relief of vaginal dryness caused by vaginal atrophy as measured by self-assessment, vaginal pH and vaginal smear.
What is the current status of trial NCT01816139?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 576 participants. The study started on 2013-01-31. Estimated completion is 2013-11-19.
What interventions are being tested in trial NCT01816139?
The interventions under investigation include: Vehicle (DRUG), WC3011 Estradiol Vaginal Cream (DRUG).
Who is sponsoring clinical trial NCT01816139?
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 NCT01816139's enrollment target sits among peer trials
576 661st of 2000 higher than 1,340 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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