Endometrial effects of lower doses of conjugated equine estrogens and medroxyprogesterone acetate: Two-year substudy results

James H. Pickar, I. Tien Yeh, James E. Wheeler, Mary F. Cunnane, Leon Speroff

Research output: Contribution to journalArticlepeer-review

79 Scopus citations

Abstract

Objective: To determine the endometrial safety of 2 years of treatment with lower doses of continuous combined conjugated equine estrogens (CEE) and medroxyprogesterone acetate (MPA). Design: Randomized, double-blind, placebo-controlled, multicenter metabolic and osteoporosis substudy of the Women's Health, Osteoporosis, Progestin, Estrogen (Women's HOPE) study. Setting: Nineteen study centers across the United States. Patient(s): Healthy, postmenopausal women (n = 822) with an intact uterus were recruited. Intervention(s): Patients received CEE 0.625, CEE 0.625/MPA 2.5, CEE 0.45, CEE 0.45/MPA 2.5, CEE 0.45/MPA 1.5, CEE 0.3, CEE 0.3/MPA 1.5 (all doses mg/day), or placebo for 2 years. Endometrial biopsies were evaluated at baseline and years 0.5, 1, 1.5, and 2 using a centralized protocol. Main Outcome Measure(s): Efficacy of lower doses of CEE/MPA in reducing the incidence of endometrial hyperplasia rates associated with unopposed estrogen (E). Result(s): No cases of endometrial hyperplasia were seen in the four CEE/MPA groups. For the CEE-alone groups, a dose-related increase in incidence rates from 3.17% (CEE 0. 3 mg) to 27.27% (CEE 0.625 mg) was seen at 2 years. The number of cases increased from year 1 to year 2. For the CEE-alone groups, the incidence rates and types of hyperplasia diagnosed varied among the pathologists. Conclusion(s): Two years of treatment with lower doses of CEE/MPA provided endometrial protection comparable to that seen with commonly prescribed doses. These regimens should be considered for postmenopausal women who are candidates for hormone therapy.

Original languageEnglish (US)
Pages (from-to)1234-1240
Number of pages7
JournalFertility and sterility
Volume80
Issue number5
DOIs
StatePublished - Nov 2003

Keywords

  • Conjugated equine estrogens
  • Endometrial hyperplasia
  • Lower doses
  • Medroxyprogesterone acetate
  • Postmenopausal estrogen therapy
  • Postmenopausal hormone therapy
  • Postmenopausal women
  • Women's HOPE study

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

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