Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation

Inclusion Criteria: * Women with vasomotor symptoms with a uterus who are postmenopausal or in late menopause transition * Body Mass Index (BMI) \<36 kg/m2 * Class I-III mammogram within 6 months of Random Periareolar Fine Needle Aspiration (RPFNA); If Class 0 or 4, must be resolved with additional procedures * If previously on oral contraceptives or hormone replacement, off for 8 weeks or more prior to baseline RPFNA; the exception is low dose vaginal hormones * Confirmed moderate risk of developing breast cancer * RPFNA results within study defined range * Kidney and liver function within study defined range * Willing and able to comply with study related procedures Exclusion Criteria: * Previous biopsy showing evidence of breast cancer * Have a predisposition to or prior history of thromboembolism, deep venous thrombosis, pulmonary embolism, or stroke * History of renal or liver disease * Prior ovarian or endometrial cancer * Stopped or started hormone replacement within 8 weeks * Any other condition or intercurrent illness that in the opinion of the investigator makes the woman a poor candidate for RPFNA * Currently taking or have taken specific medications in the past 6 months * Participation on any chemoprevention trial within 6 months * Current illness which would make potential participant unsuitable for enrollment