Multicenter Study to Evaluate Safety and Efficacy of WC3011 in Postmenopausal Women

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of this study is to compare the efficacy of WC3011 with placebo vaginal gel in postmenopausal women for the relief of vaginal dryness caused by vaginal atrophy as measured by self-assessment, vaginal pH and vaginal smear.

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

Details

• Lead Sponsor: Warner Chilcott
• Treatments: Estradiol

Criteria

Inclusion Criteria:

• Signed informed consent

• Moderate to severe vaginal dryness

• Postmenopausal meeting one of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with serum FSH (follicle stimulating hormone) > 40 mIU (milli-International Unit)/mL, 6 weeks postsurgical bilateral oophorectomy confirmed by surgical report, ultrasound or serum FSH > 40 mIU/mL, 6 weeks postsurgical hysterectomy with ovary failure confirmed by serum FSH > 40 mIU/mL

• Age ≥ 40 years or if bilateral oophorectomy ≥ 35 years

• Normal breast exam; if > 40 years, documentation of negative mammogram

Exclusion Criteria:

• Randomization in PR-04409, participation in clinical trial or use of investigational drug within 30 days prior to screening

• Smokes ≥ 15 cigarettes/day

• Known or suspected premalignant or malignant disease

• Cardiovascular disease, insulin-dependent diabetes mellitus, congestive heart failure, stroke or ischemic attack, thrombophlebitis or thromboembolic disorder

• Increased frequency/severity headaches with estrogen therapy

• Drug addiction/alcohol abuse within last 2 years

• Currently taking St. John's Wort or anticoagulant

• Uncontrolled hypertension or thyroid disorder, clinically significant depression or untreated urinary tract infection