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Estrogen Replacement and Atherosclerosis (ERA) in Older Women

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ClinicalTrials.gov Identifier: NCT00000549
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : March 16, 2016
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
To determine if estrogen replacement therapy, with or without low dose progesterone, slows progression or induces regression of coronary atherosclerosis in postmenopausal women.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Coronary Arteriosclerosis Coronary Disease Heart Diseases Myocardial Ischemia Postmenopause Drug: estrogen replacement therapy Drug: hormone replacement therapy Drug: estrogens Drug: progestins Phase 3

Detailed Description:


Cardiovascular disease is the number one cause of death in postmenopausal women. Postmenopausal estrogen replacement is associated with a lower incidence of cardiovascular disease in women, especially in those with established coronary artery disease. The strength of the apparent effect of estrogen in epidemiologic studies suggests that estrogen plays a fundamental role in the maintenance of vascular health. Animal data suggest that the current practice of adding the low dose progesterone to prevent endometrial hyperplasia may inhibit the beneficial effects of estrogen on coronary arteries. Before committing millions of postmenopausal women to long-term estrogen use for prevention of coronary artery disease, it is mandatory to demonstrate that it does indeed protect against coronary atherosclerosis, to determine the impact of co-treatment with progestin, and to understand the mechanisms through which estrogen may exert it's cardioprotective effects.

The Office of Research on Women's Health provided $500,000 in Fiscal Year 1995 for recruitment of subjects.


Randomized, placebo-controlled, blinded. The minimum diameter of coronary stenotic lesions was measured by angiography before and after three years in a group receiving unopposed estrogen replacement therapy, a group receiving estrogen replacement plus continuous low dose progestin, and a group receiving placebo. The incidence of clinical events was documented in all three groups. Secondary objectives of the trial included examining the effect of chronic and acute estrogen administration on endothelium-dependent coronary vasodilator capacity, plasma lipids and lipoproteins, antioxidant activity, blood pressure, glucose metabolism, and plasma hemostatic factors, as well as on behaviors, physical attributes, and psychosocial parameters. There were four pre-randomization variables in order to pre-stratify. These included current smoking status, insulin dependent diabetes, current lipid-lowering therapy, and the hospital where angiograms were performed.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Prevention
Study Start Date : August 1994
Actual Study Completion Date : July 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
Drug Information available for: Estrogens

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Postmenopausal women with established coronary atherosclerosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000549

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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OverallOfficial: David Herrington Bowman Gray School of Medicine

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ClinicalTrials.gov Identifier: NCT00000549    
Other Study ID Numbers: 93
U01HL049488 ( U.S. NIH Grant/Contract )
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: December 2005
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Pathologic Processes
Vascular Diseases
Arterial Occlusive Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs