Heart and Estrogen-Progestin Replacement Study (HERS)
Information source: University of California, San Francisco
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Heart Disease
Intervention: Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s):
Stephen Hulley, Principal Investigator, Affiliation: University of California, San Francisco
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.
Clinical Details
Official title: Heart and Estrogen-Progestin Replacement Study (HERS)
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Myocardial InfarctionCHD Death
Secondary outcome: CABG, revascularization, anginaserum 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
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.
Eligibility
Minimum age: 55 Years.
Maximum age: 75 Years.
Gender(s): Female.
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
- alcoholism, drug abuse
- NYHA Class IV congestive heart failure
- uncontrolled hypertension
- uncontrolled diabetes
- participation in any other investigational study
Locations and Contacts
University of California San Francisco, San Francisco, California 94143, United States
Additional Information
Starting date: July 1992
Ending date: July 2001
Last updated: April 27, 2006
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