A Safety and Efficacy Study of Estradiol Vaginal Capsule 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