Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia
NCT ID: NCT01845649
Last Updated: 2022-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
550 participants
INTERVENTIONAL
2013-04-12
2013-11-20
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 (3 Times/Week)
Vehicle applied to the vagina daily for 14 days followed by dosing 3 times per week for 10 weeks.
Vehicle
Daily for 14 days followed by 3 times per week for 10 weeks
WC3011 Estradiol Vaginal Cream (3 Times/Week)
WC3011 Estradiol vaginal cream applied daily for 14 days followed by dosing 3 times per week for 10 weeks.
WC3011 Estradiol Vaginal Cream
Daily for 14 days followed by 3 times per week for 10 weeks
Interventions
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WC3011 Estradiol Vaginal Cream
Daily for 14 days followed by 3 times per week for 10 weeks
Vehicle
Daily for 14 days followed by 3 times per week for 10 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Postmenopausal and meets 1 of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with FSH (follicle stimulating hormone) \>40 mIU/mL,6 weeks postsurgical bilateral oophorectomy with confirmation by FSH \>40 mIU/mL, surgical report or ultrasound, 6 weeks postsurgical hysterectomy with ovary failure confirmed by FSH \>40 mIU/mL
* Age ≥40 years; ≥35 with bilateral oophorectomy
* Vaginal pH \>5.0
* Less than or equal to 5% superficial cells on vaginal wall cytologic smear
* Normal clinical breast exam or negative mammogram if ≥ 40 years of age
* Negative urine pregnancy test (non-hysterectomized and \<12 months amenorrhea)
Exclusion Criteria
* Participation in clinical trial or use of investigational drug within 30 days prior to screening
* Known hypersensitivity to estrogen and/or progestin therapy
* Known or suspected premalignant or malignant disease or history steroid-dependent malignancy
* Manifestation or treatment for significant cardiovascular disease (congestive heart failure, stroke or ischemic attack, myocardial infarction, coronary artery bypass, percutaneous angioplasty or \>50% angiographic narrowing of coronary artery
* Thrombophlebitis or thromboembolic disorder or history of
* Insulin-dependent diabetes mellitus
* Increased frequency or severity of headaches while on hormone or estrogen therapy
* Currently taking St. John's Wort
* Drug/alcohol addiction within past 2 years
* Treatment with anticoagulants (heparin or warfarin)
* Smoking ≥15 cigarettes/day
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
Birmingham, Alabama, United States
Warner Chilcott Investigational Study Site
Mobile, Alabama, United States
Warner Chilcott Investigational Study Site
Chandler, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
Warner Chilcott Investigational Study Site
Sacramento, 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
San Diego, California, United States
Warner Chilcott Investigational Study Site
New London, Connecticut, United States
Warner Chilcott Investigational Study Site
Washington D.C., District of Columbia, 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
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Miami, Florida, United States
Warner Chilcott Investigational Study Site
Ormond Beach, Florida, United States
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Palm Beach Gardens, Florida, United States
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Pinellas Park, Florida, United States
Warner Chilcott Investigational Study Site
West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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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
Lexington, Kentucky, 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
Chaska, Minnesota, 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
Raleigh, North Carolina, United States
Warner Chilcott Investigational Study Site
Winston-Salem, North Carolina, United States
Warner Chilcott Investigational Study Site
Cincinnati, Ohio, 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
Warwick, Rhode Island, United States
Warner Chilcott Investigational Study Site
Bluffton, South Carolina, United States
Warner Chilcott Investigational Study Site
Greer, South Carolina, United States
Warner Chilcott Investigational Study Site
Austin, 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
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
South Jordan, 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-08112
Identifier Type: -
Identifier Source: org_study_id
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