A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy
NCT ID: NCT02670785
Last Updated: 2017-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
203 participants
INTERVENTIONAL
2016-02-15
2016-11-14
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
DOUBLE
Study Groups
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Estradiol Vaginal Capsule 0.003 mg
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Estradiol Vaginal Capsule (EVC)
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Estradiol Vaginal Capsule 0.01 mg
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Estradiol Vaginal Capsule (EVC)
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Estradiol Vaginal Capsule 0.02 mg
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Estradiol Vaginal Capsule (EVC)
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Placebo
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Placebo
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Interventions
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Estradiol Vaginal Capsule (EVC)
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Placebo
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 40 years or if bilateral oophorectomy ≥ 35 years
* Moderate to severe vaginal dryness
* Normal breast exam; if \> 40 years
* Vaginal pH \> 5.0
* \< 5% superficial cells on vaginal wall cytology smear
Exclusion Criteria
* Known or suspected premalignant or malignant disease
* Undiagnosed abnormal genital bleeding
* A history of or treatment for significant cardiovascular disease, congestive heart failure, or stroke
* Active or known protein C, protein S, or antithrombin deficient, or other known thrombophilic disorders or thromboembolic events
* Increased frequency/severity headaches with estrogen therapy
* Smokes ≥ 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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Vilma Sniukiene, MD
Role: STUDY_DIRECTOR
Allergan
Locations
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Visions Clinical Research-Tucson
Tucson, Arizona, United States
Genesis Center for Clinical Research
San Diego, California, United States
Coastal Connecticut Research, LLC
New London, Connecticut, United States
Women's Medical Research Group, LLC
Clearwater, Florida, United States
Radiant Research, Inc.
Pinellas Park, Florida, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States
Fellows Research Alliance, Inc
Savannah, Georgia, United States
Beyer Research
Kalamazoo, Michigan, United States
Office of R. Garn Mabey, M.D.
Las Vegas, Nevada, United States
Carolina Women's Research and Wellness Center
Durham, North Carolina, United States
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, United States
Women's Health Research
Columbus, Ohio, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, United States
Fellows Research Alliance, Inc
Bluffton, South Carolina, United States
Radiant Research, Inc.
Dallas, Texas, United States
Radiant Research, Inc.
San Antonio, Texas, United States
Virginia Women's Center
Richmond, Virginia, United States
Seattle Women's Health, Research, Gynecology
Seattle, Washington, United States
North Spokane Women's Clinic
Spokane, Washington, United States
Countries
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Other Identifiers
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EVC-MD-01
Identifier Type: -
Identifier Source: org_study_id
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