Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA

Exclusion criteria

• . A history of or physical examination finding for any significant cardiovascular, renal, pulmonary, neurological and hepatic diseases preventing compliance with this study.
• . A medical history of or use of anticoagulant drugs to treat or prevent coagulopathies, thrombophilia or thromboembolic disease (deep vein thrombosis, pulmonary or systemic embolism, stroke, or transient ischemic attack).
• . Uncontrolled hypertension (either systolic \> 180 mmHg or diastolic \> 105 mmHg), treatment with Class 1 antiarrhythmics or digitalis, history of congestive heart failure (New York Heart Association \[NYHA\] \> Class I), or myocardial infarction within 12 months.
• . Abnormal cervical screening test within 2 years of screening. Participant can have atypical squamous cells of undetermined significance if human papilloma virus-negative.
• . History of or current endometrial pathology: hyperplasia, carcinoma and/or polyp (prior history of a benign endometrial polyp with no current evidence of polyp is acceptable).
• . A medical history of breast cancer within 5 years of screening. Participants with a history of breast cancer more than 5 years prior to screening are considered eligible if their disease was node-negative, nonmetastatic, and if all treatment with aromatase inhibitors (AIs) or SERMs was completed at least 6 months prior to screening.
• . A medical history of malignant melanoma.
• . Any cancer (except nonmelanomatous skin cancer) diagnosed less than 5 years prior to the Screening Visit.