- Postmenopausal women of age 40 to 65 seeking treatment for hot flashes with last
natural menstrual period (LNMP) completed at least 12 months prior to screening.
- Minimum of 7 moderate to severe hot flashes per day or 50 per week recorded for 7
consecutive days
- Body Mass Index less than or equal to 34 kg/m2 using the nomograph for BMI.
- History, presence, or suspicion of estrogen-dependent neoplasia; Malignancy, or
treatment for malignancy, within the previous 2 years.
- Active or recent arterial thromboembolic disease; History of venous thromboembolism
- History of cerebrovascular accident, stroke, or transient ischemic attack -
- Presence of major depressive disorder, bipolar disorder, psychotic disorder, or
generalized anxiety disorder requiring therapy
- Persistent elevated blood pressure