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Home / Equine Research Bank / Fertil Steril / Effects of lower doses of conjugated equine estrogens and me...
Fertility and sterility2001; 75(6); 1080-1087; doi: 10.1016/s0015-0282(01)01792-7

Effects of lower doses of conjugated equine estrogens and medroxyprogesterone acetate on endometrial bleeding.

Abstract: To evaluate vaginal bleeding profiles with lower doses of conjugated equine estrogens (CEE) and medroxyprogesterone acetate (MPA) as continuous combined therapy. Methods: The Women's Health, Osteoporosis, Progestin, Estrogen (Women's HOPE) study, a randomized, double-blind, placebo-controlled trial. Methods: Study centers across the United States. Methods: Two thousand six hundred seventy-three healthy, postmenopausal women. Methods: Women received CEE, 0.625 mg/d; CEE, 0.625 mg/d, plus MPA 2.5 mg/d; CEE, 0.45 mg/d; CEE, 0.45 mg/d, plus MPA, 2.5 mg/d; CEE 0.45 mg/d, plus MPA, 1.5 mg/d; CEE, 0.3 mg/d; CEE, 0.3 mg/d, plus MPA, 1.5 mg/d; or placebo for 1 year. Methods: Bleeding data were analyzed in efficacy-evaluable and intention-to-treat populations. Results: Cumulative amenorrhea and no bleeding rates were higher with lower doses of CEE/MPA than with CEE 0.625/MPA 2.5. A linear trend between time since menopause and cumulative amenorrhea was observed (P<.05) in all CEE/MPA groups except the CEE 0.45/MPA 1.5 group. The proportion of patients who experienced no bleeding in cycle 1 was 89%, 82%, and 80% in the CEE 0.3/MPA 1.5, CEE 0.45/MPA 1.5, and CEE 0.45/MPA 2.5 groups, respectively. These values were significantly greater than the incidence of no bleeding in the CEE 0.625/MPA 2.5 group (P<.05). Conclusions: Lower-dose regimens of CEE and MPA produce higher rates of amenorrhea and no bleeding compared with CEE 0.625/MPA 2.5 and may be appropriate for newly menopausal patients.
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Publication Date: 2001-06-01 PubMed ID: 11384630DOI: 10.1016/s0015-0282(01)01792-7Google Scholar: Lookup
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  • Clinical Trial
  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support
  • Non-U.S. Gov't

Summary

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This research investigates the impact of different doses of conjugated equine estrogens (CEE) and medroxyprogesterone acetate (MPA) on endometrial bleeding in postmenopausal women. The results suggest that lower dosage regimens result in higher rates of no bleeding and may therefore be better suited for newly menopausal patients.

Study Design and Participants

  • The research was part of the Women’s Health, Osteoporosis, Progestin, Estrogen (Women’s HOPE) study, which was a randomized, double-blind, placebo-controlled trial.
  • The sample comprised of 2673 healthy, postmenopausal women from various study centers across the United States.

Methodology

  • The women were given different doses of CEE and MPA continuously as part of their therapy. The doses given were: 0.625 mg/d of CEE, 0.625 mg/d of CEE plus 2.5 mg/d of MPA, 0.45 mg/d of CEE, 0.45 mg/d of CEE plus 2.5 mg/d of MPA, 0.45 mg/d of CEE plus 1.5 mg/d of MPA, 0.3 mg/d of CEE, 0.3 mg/d of CEE plus 1.5 mg/d of MPA, or a placebo for 1 year.
  • The bleeding data were analyzed in efficacy-evaluable and intention-to-treat populations.

Results

  • The results showed that lower doses of CEE/MPA resulted in higher rates of no bleeding (amenorrhea) compared to a dose of CEE 0.625/MPA 2.5.
  • A linear trend was observed between the time since menopause and cumulative amenorrhea in all CEE/MPA groups except the CEE 0.45/MPA 1.5 group.
  • The highest incidence of no bleeding in the first cycle was seen in the CEE 0.3/MPA 1.5, CEE 0.45/MPA 1.5, and CEE 0.45/MPA 2.5 groups, which was significantly greater than the incidence in the CEE 0.625/MPA 2.5 group.

Conclusion

  • Lower dosage regimens of CEE and MPA yielded higher rates of amenorrhea and no bleeding as compared to the CEE 0.625/MPA 2.5 dose, suggesting that such lower doses may be more appropriate for newly menopausal patients.

Cite This Article

APA
Archer DF, Dorin M, Lewis V, Schneider DL, Pickar JH. (2001). Effects of lower doses of conjugated equine estrogens and medroxyprogesterone acetate on endometrial bleeding. Fertil Steril, 75(6), 1080-1087. https://doi.org/10.1016/s0015-0282(01)01792-7

Publication

Fertility and sterility
ISSN: 0015-0282
NlmUniqueID: 0372772
Country: United States
Language: English
Volume: 75
Issue: 6
Pages: 1080-1087

Researcher Affiliations

Archer, D F
  • Jones Institute for Reproductive Medicine, Norfolk, Virginia 23507, USA. archerdf@evms.edu
Dorin, M
    Lewis, V
      Schneider, D L
        Pickar, J H

          MeSH Terms

          • Amenorrhea / physiopathology
          • Animals
          • Cohort Studies
          • Double-Blind Method
          • Endometrium / blood supply
          • Estrogens, Conjugated (USP) / administration & dosage
          • Estrogens, Conjugated (USP) / adverse effects
          • Female
          • Horses
          • Humans
          • Medroxyprogesterone Acetate / administration & dosage
          • Medroxyprogesterone Acetate / adverse effects
          • Treatment Outcome
          • Uterine Hemorrhage / physiopathology

          Citations

          This article has been cited 15 times.
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