Evaluate Long-Term Safety and Efficacy WC3011

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Warner Chilcott
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Completed Study PR-04409

Exclusion Criteria:

• Developed any of the following during Study-PR04409 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