CompletedPhase 3

Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)

United States309 participantsStarted 2011-10-20

Plain-language summary

This is an open-label extension study evaluating the long-term safety and efficacy of WC3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.

Who can participate

Age range35 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Completed Study PR-04409.3 (NCT01400776) Exclusion Criteria: Developed any of the following during Study-PR04409.3 or has begun taking hormone therapy other than WC3011: * Hypersensitivity to estrogen and/or progestin therapy * Known or suspected premalignant or malignant disease (except successfully treated skin cancers) * Manifestation of or treatment for significant cardiovascular disease, stroke or ischemic attack * Insulin-dependent diabetes mellitus * Smoking ≥ 15 cigarettes daily * Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHG or diastolic ≥ 95 mmHg

What they're measuring

Number of Participants With Endometrial Biopsy Results at Final Visit

Timeframe: Final Visit (Day closest to Day 281)

Trial details

NCT IDNCT01455597

SponsorWarner Chilcott

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-12-03

Results submitted2022-04-11

View on ClinicalTrials.gov More Vulvovaginal Atrophy trials