Heart and Estrogen-Progestin Replacement Study (HERS)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Sex
Ages
Volunteers
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
- alcoholism, drug abuse
- NYHA Class IV congestive heart failure
- uncontrolled hypertension
- uncontrolled diabetes
- participation in any other investigational study
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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