Heart and Estrogen-Progestin Replacement Study (HERS)

April 27, 2006 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

2430

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Myocardial Infarction
CHD Death

Secondary Outcome Measures

Outcome Measure
quality of life
adverse effects
stroke
serum lipids
CABG, revascularization, angina
compliance
incidence of uterine bleeding and endometrial hyperplasia
incidencet and severity of vasomotor and genitourinary symptoms
thromboembolic events
symptomatic gallbladder disease
fractures
cancer
peripheral arterial disease
total mortality

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Stephen Hulley, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1992

Study Completion

July 1, 2001

Study Registration Dates

First Submitted

April 27, 2006

First Submitted That Met QC Criteria

April 27, 2006

First Posted (Estimate)

April 27, 2006

Study Record Updates

Last Update Posted (Estimate)

April 27, 2006

Last Update Submitted That Met QC Criteria

April 27, 2006

Last Verified

January 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 713B-401-US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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