Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115024
Status:
COMPLETED
Last Update Posted:
2009-12-11
First Post:
2005-06-20
Brief Title:
EPAT Estrogen in the Prevention of Atherosclerosis Trial
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Estrogen in the Prevention of Atherosclerosis Trial
Status:
COMPLETED
Status Verified Date:
2005-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The primary goal of this randomized controlled trial is to determine if ERT stabilizes retards andor 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 1mgday or a matching placebo tablet daily All women will be on a low fatlow cholesterol diet and will receive pravastatin if their LDL cholesterol level exceeds 160 mgdL 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
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 1mgday or a matching placebo tablet daily All women will be on a low fatlow cholesterol diet and will receive pravastatin if their LDL cholesterol level exceeds 160 mgdL 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG018798 | NIH | None | httpsreporternihgovquickSearchR01AG018798 |