Estrogen Replacement and Atherosclerosis (ERA) in Older Women
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| ClinicalTrials.gov Identifier: NCT00000549 |
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Recruitment Status :
Completed
First Posted : October 28, 1999
Last Update Posted : March 16, 2016
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| 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 |
BACKGROUND:
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.
DESIGN NARRATIVE:
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.
| Study Type : | Interventional (Clinical Trial) |
| Allocation: | Randomized |
| Primary Purpose: | Prevention |
| Study Start Date : | August 1994 |
| Actual Study Completion Date : | July 2000 |
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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 |
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
| OverallOfficial: | David Herrington | Bowman Gray School of Medicine |
| 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 |
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Cardiovascular Diseases Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Arteriosclerosis Ischemia Pathologic Processes |
Vascular Diseases Arterial Occlusive Diseases Hormones Estrogens Progestins Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |