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

Completed · Phase 2 · Has a placebo group

Conditions studied: Vulvovaginal Atrophy, Menopause, Dyspareunia

In brief

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

Key facts

Study ID

NCT02670785

Run by

Warner Chilcott

People needed

203

Starts

2016-02-15

Expected to finish

2016-11-14

Last updated by the study team

2017-08-23

Who can join

Age: 35 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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