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.


METHODS
International, multicenter, randomized, double-blind, placebo- and active-controlled, phase III study (Selective estrogen Menopause And Response to Therapy [SMART]-1).


METHODS
Outpatient clinical.


METHODS
Healthy, postmenopausal women (N = 3,397) aged 40 to 75 years with an intact uterus.


METHODS
Daily oral therapy with BZA 10, 20, or 40 mg, each with CE 0.625 or 0.45 mg, raloxifene 60 mg, or placebo.


METHODS
Cumulative amenorrhea profiles and the incidence of bleeding or spotting over 2 years.


RESULTS
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.


CONCLUSIONS
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.
Archer
David F
DF
CONRAD Clinical Research Center, Eastern Virginia Medical School, Norfolk, Virginia. Electronic address: archerdf@evms.edu.
Lewis
Vivian
V
University of Rochester Medical Center, Rochester, New York.
Carr
Bruce R
BR
University of Texas Southwestern Medical Center, Dallas, Texas.
Olivier
Sophie
S
Wyeth Research, Collegeville, Pennsylvania.
Pickar
James H
JH
Wyeth Research, Collegeville, Pennsylvania.
D000328:Adult; D000368:Aged; D000568:Amenorrhea / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004717:Endometrium / Q000187:drug effects; D004967:Estrogens / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D004966:Estrogens, Conjugated (USP) / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015994:Incidence; D007211:Indoles / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D008875:Middle Aged; D010045:Outpatients; D017698:Postmenopause; D020845:Selective Estrogen Receptor Modulators / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome; D014592:Uterine Hemorrhage / Q000453:epidemiology / Q000517:prevention & control*
D004967:Estrogens; D004966:Estrogens, Conjugated (USP); D007211:Indoles; D020845:Selective Estrogen Receptor Modulators; C447119:bazedoxifene