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

A Phase 2, Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate Safety and Efficacy of Three Doses of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy

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

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