Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women

Completed · Phase 3

Conditions studied: Postmenopausal Vulvovaginal Atrophy

In brief

Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.

Key facts

Study ID

NCT01400776

Run by

Warner Chilcott

People needed

722

Starts

2011-06-29

Expected to finish

2012-02-27

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…

• Postmenopausal females ≥35 years with either or both ovaries removed or naturally menopausal with moderate to severe vaginal dryness

You may not qualify if…

• 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, congestive heart failure, stroke or ischemic attacks
• Insulin-dependent diabetes mellitus
• Increased frequency or severity of headaches while on hormone or estrogen therapy
• Drug or alcohol addiction within last 2 years
• Participation in a clinical trial within 30 days
• Smoking ≥ 15 cigarettes daily
• Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 95 mmHg

Where it is running

• Mobile OB-GYN, PC — 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
• Physicians' Research Options LLC — Lakewood, Colorado, United States
• Costal Connecticut Resarch, 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 — 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
• Soapstone Center for Clinical Research — Decatur, Georgia, United States
• Atlanta North Gynecology, PC — Roswell, Georgia, United States
• Fellows Research Alliance, Inc. — Savannah, Georgia, United States
• Medical Affiliated Research Center, Inc. — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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