Heart and Estrogen-Progestin Replacement Study (HERS)

Coronary Heart Disease Clinical Trial

Official title:

Heart and Estrogen-Progestin Replacement Study (HERS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00319566
• Other study ID #: 713B-401-US
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2006
• Last updated: April 27, 2006
• Start date: July 1992
• Est. completion date: July 2001

Study information

• Verified date: January 2002
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2430
• Est. completion date: July 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial Infarction
Primary	CHD Death
Secondary	CABG, revascularization, angina
Secondary	serum lipids
Secondary	quality of life
Secondary	compliance
Secondary	incidence of uterine bleeding and endometrial hyperplasia
Secondary	incidencet and severity of vasomotor and genitourinary symptoms
Secondary	adverse effects
Secondary	thromboembolic events
Secondary	symptomatic gallbladder disease
Secondary	fractures
Secondary	cancer
Secondary	stroke
Secondary	peripheral arterial disease
Secondary	total mortality