Bazedoxifene/conjugated estrogens (BZA/CE): incidence of uterine bleeding in postmenopausal women
Objective To evaluate the effect of bazedoxifene/conjugated estrogens (BZA/CE), a tissue selective estrogen complex, on uterine bleeding in postmenopausal women. Design International, multicenter, randomized, double-blind, placebo- and active-controlled, phase III study (Selective estrogen Menopause...
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Published in | Fertility and sterility Vol. 92; no. 3; pp. 1039 - 1044 |
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Main Authors | , , , , |
Format | Journal Article |
Language | English |
Published |
New York, NY
Elsevier Inc
01.09.2009
Elsevier |
Subjects | |
Online Access | Get full text |
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Summary: | Objective To evaluate the effect of bazedoxifene/conjugated estrogens (BZA/CE), a tissue selective estrogen complex, on uterine bleeding in postmenopausal women. Design International, multicenter, randomized, double-blind, placebo- and active-controlled, phase III study (Selective estrogen Menopause And Response to Therapy [SMART]-1). Setting Outpatient clinical. Patient(s) Healthy, postmenopausal women (N = 3,397) aged 40 to 75 years with an intact uterus. Intervention(s) Daily oral therapy with BZA 10, 20, or 40 mg, each with CE 0.625 or 0.45 mg, raloxifene 60 mg, or placebo. Main Outcome Measure(s) Cumulative amenorrhea profiles and the incidence of bleeding or spotting over 2 years. Result(s) Treatment with BZA 20 or 40 mg with CE 0.625 or 0.45 mg was associated with rates of cumulative amenorrhea (>83% during cycles 1–13 and >93% during cycles 10–13) and bleeding or spotting that were comparable to those with placebo. Subjects who received BZA 10 mg/CE 0.625 mg experienced slightly lower cumulative amenorrhea rates throughout the study compared with placebo-treated subjects. Conclusion(s) Postmenopausal women treated with BZA 20 or 40 mg with CE 0.625 or 0.45 mg had high rates of cumulative amenorrhea that were similar to those reported with placebo. This new menopausal therapy may offer a favorable bleeding and tolerability profile. |
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ISSN: | 0015-0282 1556-5653 |
DOI: | 10.1016/j.fertnstert.2009.05.093 |