Ignite Creation Date:
2024-05-05 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000559
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
1999-10-27
Brief Title:
Womens EstrogenProgestin Lipid Lowering Hormone Atherosclerosis Regression Trial WELL-HART
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:
2005-05
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 the effects in postmenopausal women of hormone replacement therapy on progressionregression of coronary heart disease as measured by quantitative angiography
Detailed Description:
BACKGROUND
The trial was a logical extension of preceding observational and cross-sectional studies on estrogen replacement therapy Overall the studies suggested a 50 percent reduction in risk of coronary heart disease in current estrogen users compared to non-users In spite of such striking findings most studies had been prone to a number of biases One major criticism of observational studies had been that women receiving estrogen were generally healthier and more compliant than non-estrogen users
There was a very large body of observational data suggesting that the use of estrogen in postmenopausal women reduced coronary heart disease mortality by approximately 45 percent At the same time there had been some concern that replacement therapy increased the likelihood of uterine cancer and perhaps breast cancer as well although it was generally accepted that this risk was probably significantly less than the benefits obtained from the reduction of coronary heart disease mortality
DESIGN NARRATIVE
Randomized double-blind placebo-controlled After baseline angiograms patients were randomized to one of three arms micronized 17-beta estradiol 1 milligram per day 17-beta estradiol plus medroxyprogesterone 5 milligrams per day for twelve days per month and placebo Subjects in all three arms received lipid-lowering therapy low fatlow cholesterol diet and the HMG-CoA reductase inhibitor pravastatin in sufficient dosage to reduce low density lipoprotein LDL cholesterol levels below 130 mgdl The primary endpoint was progressionregression of coronary obstructive disease as measured by angiography including the expert human panel and quantitative computer analysis The secondary endpoint was carotid media-intima thickness determined by ultrasound Clinical measures included lipids lipoproteins apolipoproteins estradiol and medroxyprogesterone levels urinary prostanoid metabolites and insulinglucose metabolism Subjects were recruited at three centers with active coronary angiography units Several core facilities supported the study a Core Lipid Lab a Reproductive Endocrine Lab the Biostatistics Lab Data Coordinating Center and the Angiographic Imaging Laboratory
The study completion date listed in this record was obtained from the Completed Date entered in the Query View Report System QVR
The trial was a logical extension of preceding observational and cross-sectional studies on estrogen replacement therapy Overall the studies suggested a 50 percent reduction in risk of coronary heart disease in current estrogen users compared to non-users In spite of such striking findings most studies had been prone to a number of biases One major criticism of observational studies had been that women receiving estrogen were generally healthier and more compliant than non-estrogen users
There was a very large body of observational data suggesting that the use of estrogen in postmenopausal women reduced coronary heart disease mortality by approximately 45 percent At the same time there had been some concern that replacement therapy increased the likelihood of uterine cancer and perhaps breast cancer as well although it was generally accepted that this risk was probably significantly less than the benefits obtained from the reduction of coronary heart disease mortality
DESIGN NARRATIVE
Randomized double-blind placebo-controlled After baseline angiograms patients were randomized to one of three arms micronized 17-beta estradiol 1 milligram per day 17-beta estradiol plus medroxyprogesterone 5 milligrams per day for twelve days per month and placebo Subjects in all three arms received lipid-lowering therapy low fatlow cholesterol diet and the HMG-CoA reductase inhibitor pravastatin in sufficient dosage to reduce low density lipoprotein LDL cholesterol levels below 130 mgdl The primary endpoint was progressionregression of coronary obstructive disease as measured by angiography including the expert human panel and quantitative computer analysis The secondary endpoint was carotid media-intima thickness determined by ultrasound Clinical measures included lipids lipoproteins apolipoproteins estradiol and medroxyprogesterone levels urinary prostanoid metabolites and insulinglucose metabolism Subjects were recruited at three centers with active coronary angiography units Several core facilities supported the study a Core Lipid Lab a Reproductive Endocrine Lab the Biostatistics Lab Data Coordinating Center and the Angiographic Imaging Laboratory
The study completion date listed in this record was obtained from the Completed Date entered in the Query View Report System QVR
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?: