Table 1.

Study designs for Phase III clinical trials of BZA/CE

	SMART-124–27	SMART-228	SMART-329
Duration	2 years	12 weeks	12 weeks
Design	Randomized, double-blind, placebo-controlled, Phase III study
Treatments	BZA 10, 20, or 40 mg/CE 0.45 or 0.625 mg RLX 60 mg Placebo	BZA 20 mg/CE 0.45 or 0.625 mg Placebo	BZA 20 mg/CE 0.45 or 0.625 mg BZA 20 mg Placebo
Enrolled	Healthy, postmenopausal women with an intact uterus
	Aged 40–75 years	Aged 40–65 years ≥7 moderate-to-severe hot flushes per day (or ≥50 per week)	Aged 40–65 years ≥1 moderate-to-severe symptom of VV A
Primary endpoints	Incidence of endometrial hyperplasia	Frequency/severity of hot flushes	Four coprimary measures of VV A (proportion of vaginal superficial cells, proportion of parabasal cells, vaginal pH, most bothersome symptom)
Secondary endpoints	BMD, BTM, frequency/severity of hot flushes, measures of VV A, sleep, QoL	Sleep, QoL	Sexual function, satisfaction with treatment, QoL

Abbreviations: BZA, bazedoxifene; CE, conjugated estrogens; SMART, Selective estrogens, Menopause, And Response to Therapy; RLX, raloxifene; VV A, vulvar vaginal atrophy; BMD, bone mineral density; BTM, bone turnover markers; QoL, quality of life.