Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006313
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-09-28
Brief Title:
Hormone Therapy Effects on CVD Risk Factors
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:
2002-09
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 conduct extended analysis of the Postmenopausal EstrogenProgestins Intervention PEPI trial database to address questions related to cardiovascular disease risk factor response and the possible determinants of this response
Detailed Description:
BACKGROUND
Cardiovascular disease is the leading cause of death among postmenopausal women Growing evidence exists that hormone replacement therapy HRT may reduce cardiovascular disease and mortality This has led to the use of postmenopausal HRT for primary prevention of heart disease however it remains unresolved which women are likely to benefit most from this clinical approach This is a complicated question because many potential mechanisms are involved by which hormone therapy HRT may confer cardioprotection The Postmenopausal EstrogenProgestins Intervention PEPI trial examined the relative impact of four regimens of hormone therapy on a range of cardiovascular disease risk factors eg lipids blood pressure insulinglucose hemostasis factors The trial was well conducted its data have been thoroughly edited and have yielded a series of important publications To date however publications have focused on average effects without a thorough exploration of the range of and interplay among the various effects across the 875 enrolled in the trial
DESIGN NARRATIVE
The study extended the analysis of PEPI data by 1 characterizing the distributions of responses to hormone therapy with respect to risk factors for cardiovascular disease lipidslipoproteins blood pressure insulinglucose hemostasis factors 2 examining the multivariate patterns of treatment effects among these cardiovascular risk factors and on other outcomes symptomatology bone endometrial 3 examining clinical and demographic factors that may affect these relationships and in doing so characterizing women who may vary with respect to their sensitivity to the separate effects of estrogen and progestin therapy 4 examining closely patterns of adherence and their relationship to response An experienced team of statisticiansepidemiologists conducted and planned to publish results from these analyses
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 leading cause of death among postmenopausal women Growing evidence exists that hormone replacement therapy HRT may reduce cardiovascular disease and mortality This has led to the use of postmenopausal HRT for primary prevention of heart disease however it remains unresolved which women are likely to benefit most from this clinical approach This is a complicated question because many potential mechanisms are involved by which hormone therapy HRT may confer cardioprotection The Postmenopausal EstrogenProgestins Intervention PEPI trial examined the relative impact of four regimens of hormone therapy on a range of cardiovascular disease risk factors eg lipids blood pressure insulinglucose hemostasis factors The trial was well conducted its data have been thoroughly edited and have yielded a series of important publications To date however publications have focused on average effects without a thorough exploration of the range of and interplay among the various effects across the 875 enrolled in the trial
DESIGN NARRATIVE
The study extended the analysis of PEPI data by 1 characterizing the distributions of responses to hormone therapy with respect to risk factors for cardiovascular disease lipidslipoproteins blood pressure insulinglucose hemostasis factors 2 examining the multivariate patterns of treatment effects among these cardiovascular risk factors and on other outcomes symptomatology bone endometrial 3 examining clinical and demographic factors that may affect these relationships and in doing so characterizing women who may vary with respect to their sensitivity to the separate effects of estrogen and progestin therapy 4 examining closely patterns of adherence and their relationship to response An experienced team of statisticiansepidemiologists conducted and planned to publish results from these analyses
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 |
|---|---|---|---|
| R03HL062429 | NIH | None | httpsreporternihgovquickSearchR03HL062429 |