Bazedoxifene effects on the reproductive tract in postmenopausal women at risk for osteoporosis.

  • Pinkerton J
  • Archer D
  • Utian W
 et al. 
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OBJECTIVE: The aim of this study was to examine the endometrial, ovarian, and breast safety of bazedoxifene, a novel selective estrogen-receptor modulator, in postmenopausal women at risk for osteoporosis.

METHODS: Healthy postmenopausal women (N = 1,583; mean age, 57.6 y) with lumbar spine or femoral neck bone mineral density T scores between -1 and -2.5 and/or other clinical risk factors for osteoporosis were enrolled in a 24-month, phase 3, randomized, double-blind, placebo- and active-controlled trial. They received daily treatment with bazedoxifene 10, 20, or 40 mg; placebo; or raloxifene 60 mg. Reproductive safety assessments included periodic transvaginal ultrasound measurements of endometrial thickness, ovarian volume, and presence of ovarian cysts; periodic endometrial biopsies; and adverse event reporting.

RESULTS: Bazedoxifene was not associated with a significant change from baseline in mean endometrial thickness at month 24. The percentage of participants with a change from baseline in endometrial thickness or endometrial thickness greater than 5 mm at month 24 was similar among groups. There was no consensus diagnosis of endometrial hyperplasia or malignancy in the bazedoxifene or raloxifene groups; the rates of other histologic findings, including endometrial polyps, were low (
CONCLUSION: A favorable endometrial, ovarian, and breast safety profile was found after 2 years of treatment with bazedoxifene in healthy, recently postmenopausal women at risk for osteoporosis.

Author-supplied keywords

  • Bone Density
  • Breast
  • Breast Neoplasms
  • Breast Neoplasms: chemically induced
  • Breast Neoplasms: epidemiology
  • Breast: drug effects
  • Double-Blind Method
  • Endometrial Hyperplasia
  • Endometrial Hyperplasia: chemically induced
  • Endometrial Hyperplasia: epidemiology
  • Endometrial Neoplasms
  • Endometrial Neoplasms: chemically induced
  • Endometrial Neoplasms: epidemiology
  • Endometrium
  • Endometrium: drug effects
  • Endometrium: ultrasonography
  • Female
  • Humans
  • Indoles
  • Indoles: administration & dosage
  • Indoles: adverse effects
  • Middle Aged
  • Osteoporosis, Postmenopausal
  • Osteoporosis, Postmenopausal: prevention & control
  • Ovarian Cysts
  • Ovarian Cysts: chemically induced
  • Ovarian Cysts: epidemiology
  • Ovarian Neoplasms
  • Ovarian Neoplasms: chemically induced
  • Ovarian Neoplasms: epidemiology
  • Ovary
  • Ovary: drug effects
  • Ovary: ultrasonography
  • Placebos
  • Postmenopause
  • Risk Factors
  • Selective Estrogen Receptor Modulators
  • Selective Estrogen Receptor Modulators: adverse ef

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  • JoAnn V Pinkerton

  • David F Archer

  • Wulf H Utian

  • José C Menegoci

  • Amy B Levine

  • Arkadi a Chines

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