A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:35 - Any
Updated:8/10/2016
Start Date:February 2016
End Date:November 2016
Contact:Clinical Trials Registry Team
Email:IR-CTRegistration@Allergan.com

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A Phase 2, Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate Safety and Efficacy of Three Doses of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy

This study will access the safety and efficacy of three doses of estradiol vaginal capsules
in postmenopausal women with vulvovaginal atrophy.


Inclusion Criteria:

- Clinical diagnosis of vulvovaginal atrophy due to post menopause

- 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 hypersensitivity to estrogen and/or progestin therapy

- 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
We found this trial at
20
sites
Bluffton, South Carolina 29910
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Bluffton, SC
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Clearwater, Florida 33759
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Clearwater, FL
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Cleveland, Ohio 44195
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Cleveland, OH
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Columbus, Ohio 43221
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Columbus, OH
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Dallas, Texas 75231
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Dallas, TX
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Durham, North Carolina 27713
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Durham, NC
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Kalamazoo, Michigan 49009
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Kalamazoo, MI
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Las Vegas, Nevada 89119
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Las Vegas, NV
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New London, Connecticut 06320
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New London, CT
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Philadelphia, Pennsylvania 19124
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Philadelphia, PA
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Pinellas Park, Florida 33781
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Pinellas Park, FL
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Richmond, Virginia 23230
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Richmond, VA
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San Antonio, Texas 78229
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San Antonio, TX
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San Diego, California 92108
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San Diego, CA
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Savannah, Georgia 31405
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Savannah, GA
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Seattle, Washington 98104
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Seattle, WA
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Spokane, Washington 99207
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Spokane, WA
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Tucson, Arizona 85724
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Tucson, AZ
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West Palm Beach, Florida 33409
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West Palm Beach, FL
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Winston Salem, North Carolina 27103
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Winston Salem, NC
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