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Heart and Estrogen-Progestin Replacement Study (HERS)

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00319566
First received: April 27, 2006
Last updated: NA
Last verified: January 2002
History: No changes posted
  Purpose

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 Intervention Phase
Coronary Heart Disease
 Drug: Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Heart and Estrogen-Progestin Replacement Study (HERS)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Myocardial Infarction
  • CHD Death

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

Estimated Enrollment: 2430
Study Start Date: July 1992
Estimated Study Completion Date: July 2001
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.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319566

Locations
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
Investigators
Principal Investigator: Stephen Hulley University of California, San Francisco
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00319566     History of Changes
Other Study ID Numbers: 713B-401-US
Study First Received: April 27, 2006
Last Updated: April 27, 2006
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 19, 2013