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Completed

NCT Number: NCT00319566

Heart and Estrogen-Progestin Replacement Study (HERS)

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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

55 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of California San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily

Drug

Primary outcomes

  1. Myocardial Infarction

  2. CHD Death

Secondary outcomes

  1. CABG, revascularization, angina

  2. serum lipids

  3. quality of life

  4. compliance

  5. incidence of uterine bleeding and endometrial hyperplasia

  6. incidencet and severity of vasomotor and genitourinary symptoms

  7. adverse effects

  8. thromboembolic events

  9. symptomatic gallbladder disease

  10. fractures

  11. cancer

  12. stroke

  13. peripheral arterial disease

  14. total mortality

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Important dates

Study start
1992
Study completion
2001
First posted
Apr 27, 2006
Registry last updated
Apr 27, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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