Conjugated estrogen/bazedoxifene tablets for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.

Conjugated estrogen/bazedoxifene (CE/BZA) therapy represents a new, progestin-free treatment in the management of postmenopausal health. CE/BZA pairs CE with the selective estrogen receptor modulator, BZA. The rationale for the development of CE/BZA was that BZA, acting primarily as a selective estrogen receptor degrader in uterine and breast tissue, would sufficiently inhibit the proliferative effects of CE on the endometrium. The absence of a progestin would reduce the incidence of uterine bleeding, breast pain and increased breast density associated with progestin-containing hormone therapy. CE/BZA has been evaluated in five multicenter, randomized, double-blind, placebo-controlled, and active-controlled Phase III trials known as the SMART trials. CE/BZA has been shown to maintain the established benefits of estrogen therapy for treatment of vasomotor symptoms and prevention of a loss in bone mineral density (bone mass), while minimizing certain estrogenic effects, particularly in the uterine endometrium and breast.