The oestrogen/bazedoxifene combination is indicated for the treatment of oestrogen deficiency symptoms in postmenopausal women with an intact uterus and progestin intolerance.
It has not been compared with the oestrogen/progestin combination. Approval was based on a series of pivotal placebo-controlled trials where the daily number of moderate and severe hot flashes was reduced by near 3.
Its long-term safety profile is unknown due to the short duration of trials. Endometrial, thromboembolic, and cardiovascular safety were included in the risk management plan. The adverse event most frequently reported was abdominal pain (10%).