The Tissue-Selective Estrogen Complex (TSEC): A Promising New Therapy for Menopausal Symptoms and Postmenopausal Osteoporosis

Abstract

The menopausal transition may be associated with bothersome symptoms and increased risk of osteoporosis that can decrease quality of life for women. The primary treatment option is hormone therapy, which has been associated with some safety and tolerability concerns. The tissue-selective estrogen complex (TSEC) is a novel therapy that pairs a selective estrogen receptor modulator with one or more estrogens. The first TSEC in clinical development partners bazedoxifene (BZA) with conjugated estrogens (CE) and has been evaluated in the phase 3 Selective estrogens, Menopause, And Response to Therapy (SMART) trials. BZA 20 mg/CE 0.45 and 0.625 mg have been shown to be effective in reducing the frequency and severity of hot flushes and improving measures of vulvar/vaginal atrophy. These BZA/CE doses have also been shown to increase bone mineral density and reduce bone turnover without stimulating the endometrium and breast. BZA/CE represents a promising new therapy for postmenopausal women.