Multicenter Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women
NCT ID: NCT01816139
Last Updated: 2022-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
576 participants
INTERVENTIONAL
2013-01-31
2013-11-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Vehicle (2 Times/Week)
Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
Vehicle
Vehicle Cream applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks
WC3011 Estradiol Vaginal Cream (2 Times/Week)
WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
WC3011 Estradiol Vaginal Cream
WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks
Interventions
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Vehicle
Vehicle Cream applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks
WC3011 Estradiol Vaginal Cream
WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe vaginal dryness
* Postmenopausal meeting one of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with serum Follicle-stimulating hormone (FSH) \> 40 milli-International Unit (mIU)/mL, 6 weeks postsurgical bilateral oophorectomy confirmed by surgical report, ultrasound or serum FSH \> 40 mIU/mL, 6 weeks postsurgical hysterectomy with ovary failure confirmed by serum FSH \> 40 mIU/mL
* Age ≥ 40 years or if bilateral oophorectomy ≥ 35 years
* Vaginal pH \>5.0
* Less than or equal 5% superficial cells on vaginal wall cytologic smear
* Normal breast exam; if \> 40 years, documentation of negative mammogram
Exclusion Criteria
* Smokes ≥ 15 cigarettes/day
* Known or suspected premalignant or malignant disease
* Cardiovascular disease, insulin-dependent diabetes mellitus, congestive heart failure, stroke or ischemic attack, thrombophlebitis or thromboembolic disorder
* Increased frequency/severity headaches with estrogen therapy
* Drug addiction/alcohol abuse within last 2 years
* Currently taking St. John's Wort or anticoagulant
* Uncontrolled hypertension or thyroid disorder, clinically significant depression or untreated urinary tract infection
35 Years
FEMALE
No
Sponsors
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Warner Chilcott
INDUSTRY
Responsible Party
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Principal Investigators
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Anna Chan, PharmD
Role: STUDY_DIRECTOR
Warner Chilcott
Locations
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Warner Chilcott Investigational Study Site
Huntsville, Alabama, United States
Warner Chilcott Investigational Study Site
Mobile, Alabama, United States
Warner Chilcott Investigational Study Site
Phoenix, Arizona, United States
Warner Chilcott Investigational Study Site
Scottsdale, Arizona, United States
Warner Chilcott Investigational Study Site
Tucson, Arizona, United States
Warner Chilcott Investigational Study Site
San Diego, California, United States
Warner Chilcott Investigational Study Site
San Diego, California, United States
Warner Chilcott Investigational Study Site
San Diego, California, United States
Warner Chilcott Investigational Study Site
New London, Connecticut, United States
Warner Chilcott Investigational Study Site
Boynton Beach, Florida, United States
Warner Chilcott Investigational Study Site
Clearwater, Florida, United States
Warner Chilcott Investigational Study Site
Jacksonville, Florida, United States
Warner Chilcott Investigational Study Site
Miami, Florida, United States
Warner Chilcott Investigational Study Site
Miami, Florida, United States
Warner Chilcott Investigational Study Site
Ormond Beach, Florida, United States
Warner Chilcott Investigational Study Site
Palm Beach Gardens, Florida, United States
Warner Chilcott Investigational Study Site
Pinellas Park, Florida, United States
Warner Chilcott Investigational Study Site
West Palm Beach, Florida, United States
Warner Chilcott Investigational Study Site
Atlanta, Georgia, United States
Warner Chilcott Investigational Study Site
Roswell, Georgia, United States
Warner Chilcott Investigational Study Site
Savannah, Georgia, United States
Warner Chilcott Investigational Study Site
Granger, Indiana, United States
Warner Chilcott Investigational Study Site
Marrero, Louisiana, United States
Warner Chilcott Investigational Study Site
New Orleans, Louisiana, United States
Warner Chilcott Investigational Study Site
Kalamazoo, Michigan, United States
Warner Chilcott Investigational Study Site
Las Vegas, Nevada, United States
Warner Chilcott Investigational Study Site
Las Vegas, Nevada, United States
Warner Chilcott Investigational Study Site
Moorestown, New Jersey, United States
Warner Chilcott Investigational Study Site
Greensboro, North Carolina, United States
Warner Chilcott Investigational Study Site
New Bern, North Carolina, United States
Warner Chilcott Investigational Study Site
Winston-Salem, North Carolina, United States
Warner Chilcott Investigational Study Site
Cleveland, Ohio, United States
Warner Chilcott Investigational Study Site
Columbus, Ohio, United States
Warner Chilcott Investigational Study Site
Jenkintown, Pennsylvania, United States
Warner Chilcott Investigational Study Site
Philadelphia, Pennsylvania, United States
Warner Chilcott Investigational Study Site
Pittsburgh, Pennsylvania, United States
Warner Chilcott Investigational Study Site
Bluffton, South Carolina, United States
Warner Chilcott Investigational Study Site
Dallas, Texas, United States
Warner Chilcott Investigational Study Site
Dallas, Texas, United States
Warner Chilcott Investigational Study Site
Dallas, Texas, United States
Warner Chilcott Investigational Study Site
Houston, Texas, United States
Warner Chilcott Investigational Study Site
San Antonio, Texas, United States
Warner Chilcott Investigational Study Site
Salt Lake City, Utah, United States
Warner Chilcott Investigational Study Site
Salt Lake City, Utah, United States
Warner Chilcott Investigational Study Site
Norfolk, Virginia, United States
Warner Chilcott Investigational Study Site
Richmond, Virginia, United States
Warner Chilcott Investigational Study Site
Seattle, Washington, United States
Warner Chilcott Investigational Study Site
Spokane, Washington, United States
Countries
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Other Identifiers
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PR-05812
Identifier Type: -
Identifier Source: org_study_id
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