Trials / Completed
CompletedNCT01455597
Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in the Treatment of Symptoms of Vulvovaginal Atrophy in Postmenopausal Women
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 309 (actual)
- Sponsor
- Warner Chilcott · Industry
- Sex
- Female
- Age
- 35 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | WC3011 Estradiol Vaginal Cream | WC3011 estradiol vaginal cream, 3 times a week for 40 weeks. |
Timeline
- Start date
- 2011-10-20
- Primary completion
- 2012-12-03
- Completion
- 2012-12-03
- First posted
- 2011-10-20
- Last updated
- 2022-05-09
- Results posted
- 2022-05-09
Locations
64 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01455597. Inclusion in this directory is not an endorsement.