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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 20, 2005 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | April 1994 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT) | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00115024 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
lipid and non-lipid factors | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | EPAT: Estrogen in the Prevention of Atherosclerosis Trial | ||||
| Official Title ICMJE | Estrogen in the Prevention of Atherosclerosis Trial | ||||
| Brief Summary | The purpose of this study is to determine the effects of estrogen replacement therapy (ERT) on the progression of early atherosclerosis in healthy postmenopausal women without preexisting cardiovascular disease (CVD). |
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| Detailed Description | The primary goal of this randomized, controlled trial is to determine if ERT stabilizes, retards, and/or reverses the progression of atherosclerosis in postmenopausal women. We will further evaluate the association of lipid and non-lipid factors of ERT-mediated reduction in the progression of early atherosclerosis. Ultrasonography will be used to measure the rate of change in the thickness of the carotid artery. Blood samples will be used for measuring lipid and non-lipid mediators of ERT. A total of 222 healthy postmenopausal women 46 to 80 years old without CVD symptoms will be randomized to receive either micronized 17B-estradiol (Estrace) 1mg/day, or a matching placebo tablet daily. All women will be on a low fat/low cholesterol diet, and will receive pravastatin if their LDL cholesterol level exceeds 160 mg/dL. Participants will undergo ultrasonography at baseline and every 6 months throughout the 2 years of randomized treatment. Measurements of lipid and non-lipid biochemical markers will also be done at baseline and every 6 months. |
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| Study Phase | Phase II, Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Micronized 17B-estradiol | ||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 222 | ||||
| Completion Date | November 1998 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 46 Years to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00115024 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | AG0026, R01AG18798 | ||||
| Study Sponsor ICMJE | National Institute on Aging (NIA) | ||||
| Collaborators ICMJE | Mead Johnson | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute on Aging (NIA) | ||||
| Verification Date | June 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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