Reduced vaginal bleeding in postmenopausal women who receive combined norethindrone acetate and low-dose ethinyl estradiol therapy versus combined conjugated equine estrogens and medroxyprogesterone acetate therapy.
Abstract: The purpose of this study was to compare the effects on vaginal bleeding patterns of continuous combined hormone replacement therapy with norethindrone acetate and ethinyl estradiol versus conjugated equine estrogens and medroxyprogesterone acetate. Methods: Three hundred fifty-seven postmenopausal women were selected randomly (in a blinded manner) to 12 months of treatment with 1 mg norethindrone acetate/5 microg ethinyl estradiol, placebo, or open-label 0.625 mg conjugated equine estrogens/2.5 mg medroxyprogesterone acetate (conjugated equine estrogens/medroxyprogesterone acetate [CEE/MPA]; Prempro). The incidence and duration of vaginal bleeding were assessed throughout the study. Statistical analyses used Cochran-Mantel-Haenszel methodology and analysis of variance. Results: At 3 months, 1 mg norethindrone acetate/5 microg ethinyl estradiol therapy reduced the incidence of bleeding (12% vs 23%; P <.029) and bleeding and/or spotting (22% vs 44%; P <.001), compared with conjugated equine estrogens/medroxyprogesterone acetate therapy. The mean duration of bleeding and bleeding and/or spotting were also reduced with 1 mg norethindrone acetate/5 microg ethinyl estradiol therapy versus conjugated equine estrogens/medroxyprogesterone acetate (P =.004 and P <.001, respectively). The incidence of cumulative amenorrhea at every monthly interval was significantly better with 1 mg norethindrone acetate/5 microg ethinyl estradiol therapy versus conjugated equine estrogens/medroxyprogesterone acetate therapy (P <.05). Associated adverse event (ie, headache, breast pain) incidence rates were similar in the 2 active treatment groups. Conclusions: The 1 mg norethindrone acetate/5 microg ethinyl estradiol therapy provides significantly better control of vaginal bleeding than conjugated equine estrogens/medroxyprogesterone acetate therapy at all time points investigated in this 12-month study.
Publication Date: 2003-01-28 PubMed ID: 12548201DOI: 10.1067/mob.2003.104Google Scholar: Lookup
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- Clinical Trial
- Comparative Study
- Journal Article
- Multicenter Study
- Randomized Controlled Trial
- Research Support
- Non-U.S. Gov't
Summary
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This research study compared hormone replacement therapies (HRT) for postmenopausal women, specifically between continuous combined norethindrone acetate and ethinyl estradiol versus conjugated equine estrogens and medroxyprogesterone acetate. The results showed that the former therapy reduced incidences and duration of vaginal bleeding more compared to the latter therapy.
Research Purpose and Method
- The goal of this research was to assess the impact of two different types of continuous combined hormone replacement therapies on postmenopausal women’s vaginal bleeding patterns.
- The two treatments being compared were norethindrone acetate and ethinyl estradiol, and conjugated equine estrogens and medroxyprogesterone acetate.
- A total of 357 postmenopausal women were selected randomly for this study and subjected to 12 months of treatment. The participants were divided into three groups: those receiving norethindrone acetate/ethinyl estradiol, those receiving a placebo, and those receiving conjugated equine estrogens/medroxyprogesterone acetate.
- Researchers monitored the incidence and duration of vaginal bleeding throughout the study. Data was then analyzed using Cochran-Mantel-Haenszel methodology and analysis of variance techniques.
Results and Findings
- The therapy with norethindrone acetate and ethinyl estradiol showed significant reduction in incidence of bleeding and spotting compared to the conjugated equine estrogens/medroxyprogesterone acetate therapy after three months.
- The mean duration of bleeding and spotting was also significantly reduced in the group treated with norethindrone acetate and ethinyl estradiol versus the other active treatment.
- The occurrence of cumulative amenorrhea, a condition where a woman misses her periods for several months, was significantly common in the group receiving norethindrone acetate/ethinyl estradiol than the other hormone therapy.
- Interestingly, the manifestation of associated adverse events, such as headaches and breast pain, was similar between the two active treatment groups.
Conclusion
- The study concluded that the norethindrone acetate and ethinyl estradiol therapy was more effective in controlling vaginal bleeding in postmenopausal women compared to the therapy with conjugated equine estrogens and medroxyprogesterone acetate.
- These findings were consistent across all the time points investigated throughout the 12-month study.
Cite This Article
APA
Simon JA, Liu JH, Speroff L, Shumel BS, Symons JP.
(2003).
Reduced vaginal bleeding in postmenopausal women who receive combined norethindrone acetate and low-dose ethinyl estradiol therapy versus combined conjugated equine estrogens and medroxyprogesterone acetate therapy.
Am J Obstet Gynecol, 188(1), 92-99.
https://doi.org/10.1067/mob.2003.104 Publication
Researcher Affiliations
- Women's Health Research Center, Laurel, MD 20707, USA. jasimon@whrc.net
MeSH Terms
- Adult
- Amenorrhea / epidemiology
- Double-Blind Method
- Estrogen Replacement Therapy
- Estrogens, Conjugated (USP) / administration & dosage
- Estrogens, Conjugated (USP) / adverse effects
- Ethinyl Estradiol / administration & dosage
- Ethinyl Estradiol / adverse effects
- Female
- Humans
- Medroxyprogesterone Acetate / administration & dosage
- Medroxyprogesterone Acetate / adverse effects
- Middle Aged
- Norethindrone / administration & dosage
- Norethindrone / adverse effects
- Norethindrone / analogs & derivatives
- Norethindrone Acetate
- Placebos
- Postmenopause
- Time Factors
- Uterine Hemorrhage / prevention & control
Citations
This article has been cited 4 times.- Romero R. Giants in Obstetrics and Gynecology Series: A profile of Leon Speroff, MD. Am J Obstet Gynecol 2017 Sep;217(3):263.e1-263.e8.
- Furness S, Roberts H, Marjoribanks J, Lethaby A. Hormone therapy in postmenopausal women and risk of endometrial hyperplasia. Cochrane Database Syst Rev 2012 Aug 15;2012(8):CD000402.
- Crandall CJ, Aragaki AK, Chlebowski RT, McTiernan A, Anderson G, Hendrix SL, Cochrane BB, Kuller LH, Cauley JA. New-onset breast tenderness after initiation of estrogen plus progestin therapy and breast cancer risk. Arch Intern Med 2009 Oct 12;169(18):1684-91.
- Archer DF. Neoplasia of the female reproductive tract: effects of hormone therapy. Endocrine 2004 Aug;24(3):259-63.
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