Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114517
Status:
COMPLETED
Last Update Posted:
2023-01-18
First Post:
2005-06-15
Brief Title:
ELITE Early Versus Late Intervention Trial With Estradiol
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Biologic Response of Menopausal Women to 17B-Estradiol
Status:
COMPLETED
Status Verified Date:
2022-12
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 examine the effects of oral 17B-estradiol estrogen on the progression of early subclinical atherosclerosis and cognitive decline in healthy postmenopausal women
Detailed Description:
The primary hypothesis to be tested is that 17B-estradiol estrogen will reduce the progression of early atherosclerosis if initiated soon after menopause when the vascular endothelium lining of blood vessels is relatively healthy versus later when the endothelium has lost its responsiveness to estrogen Ultrasonography will be used to measure the rate of change in the thickness of the carotid artery and cardiac computed tomography CT will be used to measure coronary artery calcium and coronary artery lesions The second hypothesis to be tested is that 17B-estradiol estrogen will reduce the progression of cognitive decline if initiated soon after menopause when healthy brain tissue remains responsive to estrogen versus later when brain tissue has lost its responsiveness to estrogen
A total of 643 actual 504 initially proposed postmenopausal women were randomized according to their number of years since menopause less than 6 years or 10 years or more to receive either oral 17B-estradiol 1 mg daily or matching placebo Women with a uterus will also use vaginal progesterone gel 4 or placebo gel the last ten days of each month The vaginal progesterone will be distributed in a double-blinded fashion along with the randomized treatment so that only women exposed to active treatment will receive active progesterone As initially proposed participants will undergo ultrasonography at baseline and every 6 months throughout the 2 to 5 years average 3 years of randomized treatment Participants will also undergo cognitive testing at baseline and after 3 years of randomized treatment The trial has been extended for an additional 2 to 25 years of randomized treatment overall average randomized treatment of 5 years and range of 2 to 85 years Ultrasonography will continue to be collected every 6 months and upon completion of randomized treatment participants will undergo cardiac CT for coronary artery calcium and coronary artery lesion measurements Participants will also undergo a third cognitive testing at the completion of randomized treatment
A total of 643 actual 504 initially proposed postmenopausal women were randomized according to their number of years since menopause less than 6 years or 10 years or more to receive either oral 17B-estradiol 1 mg daily or matching placebo Women with a uterus will also use vaginal progesterone gel 4 or placebo gel the last ten days of each month The vaginal progesterone will be distributed in a double-blinded fashion along with the randomized treatment so that only women exposed to active treatment will receive active progesterone As initially proposed participants will undergo ultrasonography at baseline and every 6 months throughout the 2 to 5 years average 3 years of randomized treatment Participants will also undergo cognitive testing at baseline and after 3 years of randomized treatment The trial has been extended for an additional 2 to 25 years of randomized treatment overall average randomized treatment of 5 years and range of 2 to 85 years Ultrasonography will continue to be collected every 6 months and upon completion of randomized treatment participants will undergo cardiac CT for coronary artery calcium and coronary artery lesion measurements Participants will also undergo a third cognitive testing at the completion of randomized treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG024154 | NIH | None | httpsreporternihgovquickSearchR01AG024154 |