title: Bazedoxifene/conjugated estrogens (BZA/CE): incidence of uterine bleeding in postmenopausal women.
abstract: 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.
authors.affiliation: CONRAD Clinical Research Center, Eastern Virginia Medical School, Norfolk, Virginia. Electronic address: archerdf@evms.edu.
authors.forename: David F
authors.initials: DF
authors.lastname: Archer
authors.affiliation: University of Rochester Medical Center, Rochester, New York.
authors.forename: Vivian
authors.initials: V
authors.lastname: Lewis
authors.affiliation: University of Texas Southwestern Medical Center, Dallas, Texas.
authors.forename: Bruce R
authors.initials: BR
authors.lastname: Carr
authors.affiliation: Wyeth Research, Collegeville, Pennsylvania.
authors.forename: Sophie
authors.initials: S
authors.lastname: Olivier
authors.affiliation: Wyeth Research, Collegeville, Pennsylvania.
authors.forename: James H
authors.initials: JH
authors.lastname: Pickar
mesh_terms: 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*
chemical_list: D004967:Estrogens; D004966:Estrogens, Conjugated (USP); D007211:Indoles; D020845:Selective Estrogen Receptor Modulators; C447119:bazedoxifene