HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Steiner, A. Z. Articles by Hodis, H. N. Search for Related Content PubMed PubMed Citation Articles by Steiner, A. Z. Articles by Hodis, H. N. Related Collections Menopause and HRT

Unopposed Estradiol Therapy in Postmenopausal Women

Results From Two Randomized Trials

From the Departments of ¹Obstetrics and Gynecology, ²Preventive Medicine, ³Pathology, and ⁴Medicine, and the ⁵Atherosclerosis Research Unit, University of Southern California, Keck School of Medicine, Los Angeles, California; and the ⁶Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, New York, New York.

OBJECTIVE: To estimate the rates of endometrial hyperplasia, bleeding episodes, and interventions among menopausal women receiving unopposed oral estradiol or placebo therapy with ultrasound monitoring over 3 years.

METHODS: Two-hundred eighteen healthy women with intact uteri enrolled in the Estrogen in the Prevention of Atherosclerosis Trial (EPAT) or the Women’s Estrogen-Progestin Lipid-Lowering Hormone Atherosclerosis Regression Trial (WELL-HART) were randomly assigned to either 1 mg of micronized 17ß-estradiol (n=96) or placebo (n=122) daily for up to 3 years in a double-blind fashion. Patients were followed with annual measurement of endometrial thickness using transvaginal ultrasonography. Logistic regression was used to identify predictors of uterine bleeding and endometrial biopsy.

RESULTS: Over the study periods, nine women (9.4% of patients, 95% confidence interval [CI] 3.6–15.2%) in the estradiol group developed hyperplasia. Eight of the nine cases (88.9%) of hyperplasia were simple without atypia. Women receiving estradiol were more likely than those receiving placebo to have at least one episode of uterine bleeding (67% versus 11% at 3 years, respectively, P<.001). Women in the estradiol group were also more likely to have an endometrial biopsy (48% versus 4% at 3 years, P<.001). Among women on estradiol, obesity (body mass index [BMI] greater than 30 kg/m²) significantly increased the odds of uterine bleeding compared with normal-weight patients (BMI 25 or less) (OR 3.7, 95% CI 1.2–11.8).

CONCLUSION: Short-term, unopposed estradiol therapy with gynecologic monitoring may be an option for the treatment of menopausal symptoms. Menopausal women choosing estradiol therapy, especially if obese, should anticipate uterine bleeding and the possibility of an endometrial biopsy.

CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT 00000559 and NCT 00115024

LEVEL OF EVIDENCE: I

This article has been cited by other articles:

				Uterine Effects of Unopposed Estrogen Therapy in Menopausal Women Journal Watch Women's Health, April 5, 2007; 2007(405): 1 - 1. [Full Text]

				C. B. Iglesia Menopausal Hormone Therapy: Calculating Risks and Benefits Obstet. Gynecol., March 1, 2007; 109(3): 578 - 580. [Full Text] [PDF]