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

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