TY - JOUR
T1 - Bazedoxifene/conjugated estrogens (BZA/CE)
T2 - incidence of uterine bleeding in postmenopausal women
AU - Archer, David F.
AU - Lewis, Vivian
AU - Carr, Bruce R.
AU - Olivier, Sophie
AU - Pickar, James H.
N1 - Funding Information:
D.F.A. has received research grants from and is a consultant and speaker for Wyeth. V.L. has received research grants from Wyeth. B.R.C. has served as a lecturer for Wyeth and Novo Nordisk and has received research grants from Duramed, Neurocrine, and Boehringer Ingelheim. S.O. was previously an employee of Wyeth. J.H.P. is an employee of Wyeth.
Funding Information:
This study was sponsored by Wyeth Research, Collegeville, PA. A full list of the participating investigators and study sites has been published elsewhere (22) . The medical writing assistance of Ashley O'Dunne, PhD, is greatly appreciated.
PY - 2009/9
Y1 - 2009/9
N2 - 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.
AB - 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.
KW - BZA/CE
KW - Bazedoxifene
KW - TSEC
KW - amenorrhea
KW - conjugated estrogens
KW - postmenopausal
KW - tissue selective estrogen complex
KW - uterine bleeding
UR - http://www.scopus.com/inward/record.url?scp=69049112720&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=69049112720&partnerID=8YFLogxK
U2 - 10.1016/j.fertnstert.2009.05.093
DO - 10.1016/j.fertnstert.2009.05.093
M3 - Article
C2 - 19635614
AN - SCOPUS:69049112720
SN - 0015-0282
VL - 92
SP - 1039
EP - 1044
JO - Fertility and sterility
JF - Fertility and sterility
IS - 3
ER -