Heart and Estrogen-Progestin Replacement Study (HERS)

Phase 3CompletedNCT00319566

University of California, San Francisco2,430 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

2,430

Conditions

Coronary Heart Disease

Interventions

Premarin .625 mg daily plus medroxyprogesterone 2.5 mg dailyDRUG

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 (1)

University of California San Francisco

San Francisco, California, United States

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

Data from ClinicalTrials.gov

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