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

April 27, 2006
April 27, 2006
July 1992
Not Provided
  • Myocardial Infarction
  • CHD Death
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Heart and Estrogen-Progestin Replacement Study (HERS)
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Coronary Heart Disease
Drug: Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2430
July 2001
Not Provided

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
Female
55 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00319566
713B-401-US
Not Provided
Not Provided
University of California, San Francisco
Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Stephen Hulley University of California, San Francisco
University of California, San Francisco
January 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP