Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)
Completed · Phase 3
Conditions studied: Vulvovaginal Atrophy
In brief
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.
Key facts
- Study ID
- NCT01455597
- Run by
- Warner Chilcott
- People needed
- 309
- Starts
- 2011-10-20
- Expected to finish
- 2012-12-03
- Last updated by the study team
- 2022-05-09
Who can join
Age: 35 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Completed Study PR-04409.3 (NCT01400776)
You may not qualify if…
- 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
Where it is running
- Warner Chilcott Investigational Site — Mobile, Alabama, United States
- Women's Health Research — Phoenix, Arizona, United States
- Precision Trials, LLC — Phoenix, Arizona, United States
- Radiant Research-Scottsdale — Scottsdale, Arizona, United States
- Radiant Research-Tucson — Tucson, Arizona, United States
- Visions Clinical Research-Tucson — Tucson, Arizona, United States
- Genesis Center for Clinical Research — San Diego, California, United States
- Medical Center for Clinical Research — San Diego, California, United States
- Women's Healthcare Inc. — San Diego, California, United States
- Coastal Connecticut Research, LLC — New London, Connecticut, United States
- Visions Clinical Research — Boynton Beach, Florida, United States
- Women's Medical Research Group, LLC — Clearwater, Florida, United States
- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
- Miami Research Associates — Miami, Florida, United States
- New Age Medical Research Corp — Miami, Florida, United States
- Ormond Medical Arts Pharmaceutical Research Center — Ormond Beach, Florida, United States
- OB-GYN Specialists of the Palm Beaches — Palm Beach Gardens, Florida, United States
- Radiant Research-St. Petersburg — Pinellas Park, Florida, United States
- Comprehensive Clinical Trials, LLC — West Palm Beach, Florida, United States
- Radiant Research-Atlanta — Atlanta, Georgia, United States
- Fellows Research Alliance, Inc. — Savannah, Georgia, United States
- Radiant Research-Chicago — Chicago, Illinois, United States
- Springfield Clinical, LLP — Springfield, Illinois, United States
- The South Bend Clinic, LLP — Granger, Indiana, United States
- Medical Affiliated Research Center, Inc. — Huntsville, Alabama, United States
Full record on ClinicalTrials.gov
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