Heart and Estrogen-Progestin Replacement Study (HERS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00319566
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : April 27, 2006
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Drug: Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily Phase 3

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  (Clinical Trial)
Enrollment : 2430 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Heart and Estrogen-Progestin Replacement Study (HERS)
Study Start Date : July 1992
Study Completion Date : July 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
Drug Information available for: Estrogens

Primary Outcome Measures :
  1. Myocardial Infarction
  2. CHD Death

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00319566

United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Stephen Hulley University of California, San Francisco Identifier: NCT00319566     History of Changes
Other Study ID Numbers: 713B-401-US
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: April 27, 2006
Last Verified: January 2002

Keywords provided by University of California, San Francisco:
Coronary Heart Disease
Hormone replacement therapy
Postmenopausal women

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Myocardial Ischemia
Estrogens, Conjugated (USP)
Medroxyprogesterone Acetate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents