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Heart and Estrogen-Progestin Replacement Study (HERS)


Phase 3
55 Years
75 Years
Not Enrolling
Female
Coronary Heart Disease

Thank you

Trial Information

Heart and Estrogen-Progestin Replacement Study (HERS)


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Myocardial Infarction

Principal Investigator

Stephen Hulley

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Food and Drug Administration

Study ID:

713B-401-US

NCT ID:

NCT00319566

Start Date:

July 1992

Completion Date:

July 2001

Related Keywords:

  • Coronary Heart Disease
  • Coronary Heart Disease
  • Hormone replacement therapy
  • Estrogen
  • Postmenopausal women
  • Coronary Artery Disease
  • Myocardial Ischemia
  • Coronary Disease
  • Heart Diseases

Name

Location
University of California San Francisco San Francisco, California  941104206