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A randomized, double-blind, placebo-controlled, multicenter study that assessed the endometrial effects of norethindrone acetate plus ethinyl estradiol versus ethinyl estradiol alone.

AbstractOBJECTIVE:
The purpose of this study was to determine the incidence of endometrial hyperplasia in subjects who receive continuous norethindrone acetate and ethinyl estradiol combinations versus unopposed ethinyl estradiol.
STUDY DESIGN:
Nine hundred forty-five postmenopausal women were randomly selected for 12 months of treatment with one of six blinded norethindrone acetate/ethinyl estradiol combinations (milligrams of norethindrone acetate/micrograms of ethinyl estradiol: 0/5, 0.25/5, 1/5, 0/10, 0.5/10, or 1/10) or to open-label 0.625 mg conjugated equine estrogens/2.5 mg medroxyprogesterone acetate. Endometrial hyperplasia and endometrial proliferation were assessed by biopsy at screening, months 6 and 12.
RESULTS:
Endometrial hyperplasia developed in 26 subjects: Placebo, 0/5 and 0.25/5 (1 subject each) and 0/10 (23 subjects). Significantly less endometrial proliferation was measured in the 1/5 norethindrone acetate/ethinyl estradiol and other norethindrone acetate/ethinyl estradiol combination groups and in the 0.625 mg conjugated equine estrogens/2.5 mg medroxyprogesterone acetate group, than in unopposed ethinyl estradiol groups (6 months: P <.004; 12 months: P <.001). Treatment with 1/5 norethindrone acetate/ethinyl estradiol and with other norethindrone acetate/ethinyl estradiol combinations significantly reduced endometrial proliferation compared with 0.625 mg conjugated equine estrogens/2.5 mg medroxyprogesterone acetate (6 and 12 months: P <.02).
CONCLUSION:
Norethindrone acetate protects the endometrium from estrogen-induced hyperplasia and changes in proliferative status. In addition, norethindrone acetate/ethinyl estradiol-treated subjects had significantly less endometrial proliferation compared with 0.625 mg conjugated equine estrogens/2.5 mg medroxyprogesterone acetate-treated subjects.
AuthorsDavid J Portman, James P Symons, Walter Wilborn, Nona J Kempfert
JournalAmerican journal of obstetrics and gynecology (Am J Obstet Gynecol) Vol. 188 Issue 2 Pg. 334-42 (Feb 2003) ISSN: 0002-9378 [Print] United States
PMID12592236 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Drug Combinations
  • Estradiol Congeners
  • Placebos
  • Ethinyl Estradiol
  • Norethindrone Acetate
  • Norethindrone
Topics
  • Double-Blind Method
  • Drug Combinations
  • Endometrial Hyperplasia (chemically induced, epidemiology, pathology)
  • Endometrium (drug effects, pathology)
  • Estradiol Congeners (adverse effects)
  • Ethinyl Estradiol (adverse effects)
  • Female
  • Humans
  • Incidence
  • Middle Aged
  • Norethindrone (adverse effects, analogs & derivatives)
  • Norethindrone Acetate
  • Placebos (therapeutic use)
  • Safety
  • Severity of Illness Index

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