Status:
COMPLETED
Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women
Lead Sponsor:
Warner Chilcott
Conditions:
Postmenopausal Vulvovaginal Atrophy
Eligibility:
FEMALE
35+ years
Phase:
PHASE3
Brief Summary
Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.
Eligibility Criteria
Inclusion
- Postmenopausal females ≥35 years with either or both ovaries removed or naturally menopausal with moderate to severe vaginal dryness
Exclusion
- 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
Key Trial Info
Start Date :
June 29 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2012
Estimated Enrollment :
722 Patients enrolled
Trial Details
Trial ID
NCT01400776
Start Date
June 29 2011
End Date
February 27 2012
Last Update
May 9 2022
Active Locations (70)
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1
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
2
Mobile OB-GYN, PC
Mobile, Alabama, United States, 36608
3
Women's Health Research
Phoenix, Arizona, United States, 85015
4
Precision Trials, LLC
Phoenix, Arizona, United States, 85032