title: Endometrial effects of a tissue selective estrogen complex containing bazedoxifene/conjugated estrogens as a menopausal therapy.
abstract: OBJECTIVE
  To evaluate the endometrial safety of a tissue selective estrogen complex (TSEC; pairing of a selective estrogen receptor modulator [SERM] with estrogens) composed of bazedoxifene/conjugated estrogens (BZA/CE) in postmenopausal women.
  
  
  METHODS
  Randomized, double-blind, multicenter, placebo- and active-controlled, phase 3 study (Selective estrogen Menopause And Response to Therapy [SMART]-1).
  
  
  METHODS
  Outpatient clinical.
  
  
  METHODS
  Healthy, postmenopausal women (n = 3,397) age 40-75 with an intact uterus.
  
  
  METHODS
  Single tablets of BZA (10, 20, or 40 mg) combined with CE (0.625 or 0.45 mg); raloxifene (60 mg); or placebo daily for 2 years.
  
  
  METHODS
  Incidence of endometrial hyperplasia at 12 months in the efficacy evaluable population.
  
  
  RESULTS
  Treatment with BZA (20 or 40 mg)/CE (0.625 or 0.45 mg) was associated with low rates (<1%) of endometrial hyperplasia that were not significantly different from those reported with placebo over 24 months. Endometrial thickness with BZA (20 or 40 mg)/CE (0.625 or 0.45 mg) was not significantly different from that with placebo.
  
  
  CONCLUSIONS
  When combined with CE (0.625 mg or 0.45 mg), BZA (20 mg) was the lowest effective dose that prevented endometrial hyperplasia over 2 years of study, creating the possibility for a new, progestin-free menopausal therapy.
authors.affiliation: Wyeth Research, Collegeville, Pennsylvania. Electronic address: pickarj@wyeth.com.
authors.forename: James H
authors.initials: JH
authors.lastname: Pickar
authors.affiliation: University of Texas Health Science Center, San Antonio, Texas.
authors.forename: I-Tien
authors.initials: IT
authors.lastname: Yeh
authors.affiliation: Robert Wood Johnson University Hospital, New Brunswick, New Jersey.
authors.forename: Gloria
authors.initials: G
authors.lastname: Bachmann
authors.affiliation: Oregon Health and Science University, Portland, Oregon.
authors.forename: Leon
authors.initials: L
authors.lastname: Speroff
mesh_terms: D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004714:Endometrial Hyperplasia / Q000517:prevention & control; D016889:Endometrial Neoplasms / Q000517:prevention & control; D004717:Endometrium / Q000187:drug effects* / Q000473:pathology; 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; D007211:Indoles / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D008875:Middle Aged; D010045:Outpatients; D017698:Postmenopause / Q000187:drug effects*; D011960:Receptors, Estrogen / Q000187:drug effects; D020845:Selective Estrogen Receptor Modulators / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D004967:Estrogens; D004966:Estrogens, Conjugated (USP); D007211:Indoles; D011960:Receptors, Estrogen; D020845:Selective Estrogen Receptor Modulators; C447119:bazedoxifene