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Heart and Estrogen-Progestin Replacement Study (HERS)

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Heart Disease focused on measuring Coronary Heart Disease, Hormone replacement therapy, Estrogen, Postmenopausal women

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Francisco

Outcomes

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

Full Information

First Posted
April 27, 2006
Last Updated
April 27, 2006
Sponsor
University of California, San Francisco
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00319566
Brief Title
Heart and Estrogen-Progestin Replacement Study (HERS)
Official Title
Heart and Estrogen-Progestin Replacement Study (HERS)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2002
Overall Recruitment Status
Completed
Study Start Date
July 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Coronary Heart Disease, Hormone replacement therapy, Estrogen, Postmenopausal women

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
2430 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily
Primary Outcome Measure Information:
Title
Myocardial Infarction
Title
CHD Death
Secondary Outcome Measure Information:
Title
CABG, revascularization, angina
Title
serum lipids
Title
quality of life
Title
compliance
Title
incidence of uterine bleeding and endometrial hyperplasia
Title
incidencet and severity of vasomotor and genitourinary symptoms
Title
adverse effects
Title
thromboembolic events
Title
symptomatic gallbladder disease
Title
fractures
Title
cancer
Title
stroke
Title
peripheral arterial disease
Title
total mortality

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Hulley
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

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Heart and Estrogen-Progestin Replacement Study (HERS)

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