Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

Primary: To assess the efficacy and safety of DVS-233 SR compared with placebo for treatment of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence of DVS-233 SR and tibolone. Secondary: To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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