Table 2.

Clinical phase III trials of bazedoxifene in combination with conjugated estrogen

Protocol ID	Duration	Population	Compound	Primary endpoints	Secondary endpoints
SMART-1	2 years	Postmenopausal women (n = 3397)	BAZ 10, 20, 40 mg combined with CE (0.45 or 0.625 mg) vs raloxifene 60 mg or placebo	Endometrial hyperplasia (at 1 year)	Endometrial hyperplasia(at 2 years); breast pain; effects on BMD
SMART-2	12 weeks	Postmenopausal women with hot flushes (n = 318)	BAZ 20 mg combined with CE (0.45 or0.625 mg) vs placebo	Moderate or severe hot flushes at week 4 or 12	Breast pain; sleep quality
SMART-3	12 weeks	Postmenopausal women with vaginal atrophy (n = 652)	BAZ 20 mg combined with CE (0.45 or0.625 mg) vs BAZ 20 mg or placebo	Vaginal atrophy (superficial and parabasal cells)	Sexual function; menopause related quality of life
SMART-4	2 years	Postmenopausal women (n = 1083)	BAZ 20 mg combined with CE (0.45 or 0.625 mg) vs CE (0.45 mg)/medroxyprogesterone acetate (1.5 mg) or Placebo	Endometrial hyperplasia (at 1 year); BMD change at 1 year (osteoporosis substudy)	Uterine bleeding/spotting; breast pain

Abbreviations: AE, adverse event; BMD, bone mineral density; BZA, bazedoxifene acetate; CE, conjugated estrogen; PB, placebo.