Phase 3 Study of Bazedoxifene/Conjugated Estrogen for Menopausal Symptoms

Pfizer announced results from its Phase 3 safety study of bazedoxifene/conjugated estrogen (BZA/CE) for the treatment of moderate-to-severe hot flashes, vulvar and vaginal atrophy and the prevention of osteoporosis in women following menopause. SMART-5 was a one-year, double-blind, placebo-controlled study that investigated over 1,800 postmenopausal women who had not had a hysterectomy. The study was designed to assess the safety and efficacy of two doses of BZA/CE treatment on the endometrial lining of the uterus and evaluate the efficacy of BZA/CE for the prevention of osteoporosis. All primary (incidence of endometrial hyperplasia and prevention of postmenopausal osteoporosis) and secondary endpoints (bone mineral density, breast density, sleep parameters and health-related quality of life) in SMART-5 were met. The most common adverse effects seen in women treated with BZA/CE in SMART-5 were back pain, inflammation of the nose and throat and headache.

BZA/CE contains a selective estrogen receptor modulator (SERM), bazedoxifene, and conjugated estrogens. 

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