NCT00319566
Completed
Phase 3
Heart and Estrogen-Progestin Replacement Study (HERS)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Coronary Heart Disease
- Sponsor
- University of California, San Francisco
- Enrollment
- 2430
- Locations
- 1
- Primary Endpoint
- Myocardial Infarction
- Status
- Completed
- Last Updated
- 20 years ago
Overview
Brief Summary
The purpose of the study is to determine whether hormone replacement therapy in post menopausal women with coronary artery disease prevents future heart attacks or death from coronary heart disease.
Detailed Description
A randomized, blinded trial in post menopausal women with cornaornary artery disease to test the hypothesis, among 2340 women who have a uterus, that those randomized to receive estrogen-progestin replacement therapy (Premanrin .625 mg daily plus medroxygrprogesterone acetate 2.5 mg daily) have the same frequency on new CHD events (myocardial infarction and CHD death) as those randomized to placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\<75 y.o.
- •uterus present
- •postmenopausal
- •evidence of CHD
- •signed consent
Exclusion Criteria
- •MI, CABG, mechanical revascularization within 6 months
- •serum triglyceride \>300mg/dl
- •used hormone therapy or estrogen vaginal cream in past 3 months
- •history of DVT or pulmonary embolism
- •history of breast cancer or mammogram suggestive of cancer
- •history of endometrial cancer
- •abnormal uterine bleeding
- •pap smear abnormal
- •SGOT more than 1.2 times normal
- •Disease judged to be fatal within 4 yrs
Outcomes
Primary Outcomes
Myocardial Infarction
CHD Death
Secondary Outcomes
- CABG, revascularization, angina
- serum lipids
- quality of life
- compliance
- incidence of uterine bleeding and endometrial hyperplasia
- incidencet and severity of vasomotor and genitourinary symptoms
- adverse effects
- thromboembolic events
- symptomatic gallbladder disease
- fractures
- cancer
- stroke
- peripheral arterial disease
- total mortality
Study Sites (1)
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