Status:
COMPLETED
Heart and Estrogen-Progestin Replacement Study (HERS)
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Coronary Heart Disease
Eligibility:
FEMALE
55-75 years
Phase:
PHASE3
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 rep...
Eligibility Criteria
Inclusion
- \<75 y.o.
- uterus present
- postmenopausal
- evidence of CHD
- signed consent
Exclusion
- 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
Key Trial Info
Start Date :
July 1 1992
Trial Type :
INTERVENTIONAL
End Date :
July 1 2001
Estimated Enrollment :
2430 Patients enrolled
Trial Details
Trial ID
NCT00319566
Start Date
July 1 1992
End Date
July 1 2001
Last Update
April 27 2006
Active Locations (1)
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1
University of California San Francisco
San Francisco, California, United States, 94143