Heart and Estrogen-Progestin Replacement Study (HERS) - Full Text View

Sponsor:	University of California, San Francisco
Collaborator:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00319566

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 III

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:

MedlinePlus related topics: Coronary Artery Disease Heart Attack Heart Diseases Hormone Replacement Therapy

Drug Information available for: Estrogens, conjugated Medroxyprogesterone 17-acetate Medroxyprogesterone

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 February 09, 2012