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Optimizing continuous-combined hormone replacement therapy for postmenopausal women: a comparison of six different treatment regimens.

AbstractOBJECTIVE:
We sought to determine the optimum estradiol valerate-medroxyprogesterone acetate regimens for efficacy and safety.
STUDY DESIGN:
We performed a 24-month, randomized, double-blind phase II study. Four hundred nineteen women who were postmenopausal for at least 3 years were placed in six parallel treatment groups and received 1 or 2 mg estradiol valerate with either 2.5 or 5 mg medroxyprogesterone acetate. In two groups the dose of estradiol valerate was increased from 1 to 2 mg estradiol valerate after 6 months.
RESULTS:
A marked improvement of climacteric symptoms was observed, and most women had no bleeding even during the first 3 months of treatment. The best bleeding pattern was achieved with 1 mg estradiol valerate and 2.5 or 5 mg medroxyprogesterone acetate, and in most groups the bleeding pattern improved over time. No cases of hyperplasia were observed.
CONCLUSION:
All regimens alleviated climacteric symptoms and provided excellent bleeding control, even during the early weeks of treatment. A choice of various dose combinations offers flexibility of dosing, thus enabling therapy to be tailored to the needs of individual women.
AuthorsJ E Heikkinen, R T Vaheri, S M Ahomäki, P M Kainulainen, A T Viitanen, U M Timonen
JournalAmerican journal of obstetrics and gynecology (Am J Obstet Gynecol) Vol. 182 Issue 3 Pg. 560-7 (Mar 2000) ISSN: 0002-9378 [Print] United States
PMID10739508 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Drug Combinations
  • Lipids
  • Progesterone Congeners
  • Estradiol
  • Medroxyprogesterone Acetate
Topics
  • Bone Density (drug effects)
  • Climacteric (drug effects)
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Combinations
  • Endometrium (drug effects)
  • Estradiol (analogs & derivatives, therapeutic use)
  • Female
  • Hemorrhage (prevention & control)
  • Hormone Replacement Therapy
  • Humans
  • Lipids (blood)
  • Medroxyprogesterone Acetate (therapeutic use)
  • Middle Aged
  • Postmenopause (blood, drug effects, physiology)
  • Progesterone Congeners (therapeutic use)

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