Abstract | OBJECTIVE: DESIGN: SETTING: Nineteen study centers across the United States. PATIENT(S): Healthy, postmenopausal women (n = 822) with an intact uterus were recruited. INTERVENTION(S): Patients received CEE 0.625, CEE 0.625/MPA 2.5, CEE 0.45, CEE 0.45/MPA 2.5, CEE 0.45/MPA 1.5, CEE 0.3, CEE 0.3/MPA 1.5 (all doses mg/day), or placebo for 2 years. Endometrial biopsies were evaluated at baseline and years 0.5, 1, 1.5, and 2 using a centralized protocol. MAIN OUTCOME MEASURE(S): RESULT(S): No cases of endometrial hyperplasia were seen in the four CEE/MPA groups. For the CEE-alone groups, a dose-related increase in incidence rates from 3.17% (CEE 0.3 mg) to 27.27% (CEE 0.625 mg) was seen at 2 years. The number of cases increased from year 1 to year 2. For the CEE-alone groups, the incidence rates and types of hyperplasia diagnosed varied among the pathologists. CONCLUSION(S): Two years of treatment with lower doses of CEE/MPA provided endometrial protection comparable to that seen with commonly prescribed doses. These regimens should be considered for postmenopausal women who are candidates for hormone therapy.
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Authors | James H Pickar, I Tien Yeh, James E Wheeler, Mary F Cunnane, Leon Speroff |
Journal | Fertility and sterility
(Fertil Steril)
Vol. 80
Issue 5
Pg. 1234-40
(Nov 2003)
ISSN: 0015-0282 [Print] United States |
PMID | 14607581
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Estrogens
- Estrogens, Conjugated (USP)
- Placebos
- Medroxyprogesterone Acetate
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Topics |
- Adult
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Therapy, Combination
- Endometrial Hyperplasia
(epidemiology)
- Estrogen Replacement Therapy
- Estrogens
(administration & dosage)
- Estrogens, Conjugated (USP)
(administration & dosage)
- Female
- Humans
- Incidence
- Medroxyprogesterone Acetate
(administration & dosage)
- Middle Aged
- Placebos
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