Safety & Efficacy WC3011 in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.

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

Details

• Lead Sponsor: Warner Chilcott

Criteria

Inclusion Criteria:

• Postmenopausal females ≥35 years with either or both ovaries removed or naturally menopausal with moderate to severe vaginal dryness

Exclusion Criteria:

• 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, Congestive heart failure, stroke or ischemic attacks

• Insulin-dependent diabetes mellitus

• Increased frequency or severity of headaches while on hormone or estrogen therapy

• Drug or alcohol addiction within last 2 years

• Participation in a clinical trial within 30 days

• Smoking ≥ 15 cigarettes daily

• Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHg or diastolic ≥ 95 mmHg