Heart and Estrogen-Progestin Replacement Study (HERS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2430 participants

Study Classification

INTERVENTIONAL

Study Start Date

1992-07-31

Study Completion Date

2001-07-31

Brief Summary

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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

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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.

Conditions

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Coronary Heart Disease

Keywords

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Coronary Heart Disease Hormone replacement therapy Estrogen Postmenopausal women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Stephen Hulley

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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713B-401-US

Identifier Type: -

Identifier Source: org_study_id