Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000549
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
1999-10-27
Brief Title:
Estrogen Replacement and Atherosclerosis ERA in Older Women
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-12
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:
To determine if estrogen replacement therapy with or without low dose progesterone slows progression or induces regression of coronary atherosclerosis in postmenopausal women
Detailed Description:
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 its cardioprotective effects
The Office of Research on Womens Health provided 500000 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
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 its cardioprotective effects
The Office of Research on Womens Health provided 500000 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL049488 | NIH | None | httpsreporternihgovquickSearchU01HL049488 |