Status:
COMPLETED
Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)
Lead Sponsor:
Warner Chilcott
Conditions:
Vulvovaginal Atrophy
Eligibility:
FEMALE
35+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- Completed Study PR-04409.3 (NCT01400776)
Exclusion
- Developed any of the following during Study-PR04409.3 or has begun taking hormone therapy other than WC3011:
- Hypersensitivity to estrogen and/or progestin therapy
- Known or suspected premalignant or malignant disease (except successfully treated skin cancers)
- Manifestation of or treatment for significant cardiovascular disease, stroke or ischemic attack
- Insulin-dependent diabetes mellitus
- Smoking ≥ 15 cigarettes daily
- Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHG or diastolic ≥ 95 mmHg
Key Trial Info
Start Date :
October 20 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2012
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT01455597
Start Date
October 20 2011
End Date
December 3 2012
Last Update
May 9 2022
Active Locations (64)
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1
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
2
Warner Chilcott Investigational Site
Mobile, Alabama, United States, 36608
3
Women's Health Research
Phoenix, Arizona, United States, 85015
4
Precision Trials, LLC
Phoenix, Arizona, United States, 85032