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

• Status: Completed
• Trial end date: 2016-11-14
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• 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:

• 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

Exclusion Criteria:

• 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