Relief of vasomotor symptoms with the tissue-selective estrogen complex containing bazedoxifene/conjugated estrogens: a randomized, controlled trial

Objective: The aim of this study was to assess the safety and efficacy of bazedoxifene (BZA)/conjugated estrogens (CE) treating moderate to severe vasomotor symptoms in the Selective Estrogen Menopause and Response to Therapy 2 trial. Methods: This was an outpatient, multicenter, double-blind, randomized, placebo-controlled, phase 3 study conducted in the United States. Healthy postmenopausal women (N = 332; aged 40-65 y) with moderate to severe hot flushes (>= 7/d or 50/wk) were randomized to BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, or placebo once daily for 12 weeks. Changes from baseline in the average daily number of moderate and severe hot flushes and daily severity score were assessed at weeks 4 and 12; adverse events were recorded. Results: BZA/CE significantly reduced the number and severity of hot flushes at weeks 4 and 12 (P < 0.001). At week 12, BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg reduced hot flushes from baseline by 74% (10.3 hot flushes [baseline] vs 2.8 [week 12]) and 80% (10.4 vs 2.4), respectively, compared with 51% (10.5 vs 5.4) for placebo. More participants at week 12 had at least a 75% decrease in hot flushes with BZA 20 mg/CE 0.45 mg (61%) and BZA 20 mg/CE 0.625 mg (73%) versus placebo (27%; P < 0.001). The safety profile was similar between BZA/CE and placebo, and no unexpected safety findings were reported. Conclusions: BZA 20 mg paired with CE 0.45 or 0.625 mg is effective, with short-term safety, for treating vasomotor symptoms in postmenopausal women.