Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005466
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Stroke and MI in Users of EstrogenProgestogen
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:
2000-05
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 estimate the relative risks of acute myocardial infarction MI and of stroke in postmenopausal users of estrogenprogestogen EP combinations and to estimate the relative risks of MI and of stroke in users of estrogen alone
Detailed Description:
BACKGROUND
Post-menopausal hormone use is becoming increasingly widespread based on evidence of the benefits of estrogen use for bone and the heart However because estrogen alone substantially increases the risk of endometrial cancer estrogen users who have not undergone a hysterectomy are frequently also placed on a progestogen EP a strategy that reduces the likelihood of endometrial cancer when compared with use of estrogen alone In 1991 there were almost no data on the risk of cardiovascular disease in post-menopausal women who used EP combinations
DESIGN NARRATIVE
The study had a case-control design Cases were women hospitalized with MI or stroke in any of nine participating Northern California Kaiser Permanente hospitals in a 36 month period For each case one control matched by year of birth was selected at random from among members of the Kaiser Permanente Health Plan who were expected to use the same nine hospitals for their medical care Information about use of estrogen EP combinations past use of oral contraceptives menopause hysterectomy and oophorectomy demographics general health status preventive health care and cardiovascular risk factors were collected in interviews done of the subjects or for fatal cases a surrogate Information about then current use of estrogen and EP combinations were also gathered by reviewing medical records
The investigators used conditional logistic regression analysis to estimate the relative risks of MI and of stroke in users of EP combinations taking into account prior oophorectomy and other potential confounders They also estimated the risks of acute MI and of stroke in users of estrogen alone accounting for prior oophorectomy and potential confounders
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Post-menopausal hormone use is becoming increasingly widespread based on evidence of the benefits of estrogen use for bone and the heart However because estrogen alone substantially increases the risk of endometrial cancer estrogen users who have not undergone a hysterectomy are frequently also placed on a progestogen EP a strategy that reduces the likelihood of endometrial cancer when compared with use of estrogen alone In 1991 there were almost no data on the risk of cardiovascular disease in post-menopausal women who used EP combinations
DESIGN NARRATIVE
The study had a case-control design Cases were women hospitalized with MI or stroke in any of nine participating Northern California Kaiser Permanente hospitals in a 36 month period For each case one control matched by year of birth was selected at random from among members of the Kaiser Permanente Health Plan who were expected to use the same nine hospitals for their medical care Information about use of estrogen EP combinations past use of oral contraceptives menopause hysterectomy and oophorectomy demographics general health status preventive health care and cardiovascular risk factors were collected in interviews done of the subjects or for fatal cases a surrogate Information about then current use of estrogen and EP combinations were also gathered by reviewing medical records
The investigators used conditional logistic regression analysis to estimate the relative risks of MI and of stroke in users of EP combinations taking into account prior oophorectomy and other potential confounders They also estimated the risks of acute MI and of stroke in users of estrogen alone accounting for prior oophorectomy and potential confounders
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 |
|---|---|---|---|
| R01HL047043 | NIH | None | httpsreporternihgovquickSearchR01HL047043 |