Heart and Estrogen-Progestin Replacement Study (HERS)

Last updated: April 27, 2006
Sponsor: University of California, San Francisco
Overall Status: Completed

Phase

3

Condition

Myocardial Ischemia

Coronary Artery Disease

Heart Attack (Myocardial Infarction)

Treatment

N/A

Clinical Study ID

NCT00319566
713B-401-US
  • Ages 55-75
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • <75 y.o.

  • uterus present

  • postmenopausal

  • evidence of CHD

  • signed consent

Exclusion

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 Design

Total Participants: 2430
Study Start date:
July 01, 1992
Estimated Completion Date:
July 31, 2001

Study 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.

Connect with a study center

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.