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Stroke and MI in Users of Estrogen/Progestogen
This study has been completed.
Study NCT00005466   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: May 25, 2000   Last Updated: June 23, 2005   History of Changes

May 25, 2000
June 23, 2005
August 1991
 
 
 
Complete list of historical versions of study NCT00005466 on ClinicalTrials.gov Archive Site
 
 
 
Stroke and MI in Users of Estrogen/Progestogen
 

To estimate the relative risks of acute myocardial infarction (MI) and of stroke in postmenopausal users of estrogen/progestogen (E/P) combinations and to estimate the relative risks of MI and of stroke in users of estrogen alone.

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 (E/P), 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 E/P 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, E/P 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 E/P 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 E/P 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.

 
Observational
Observational Model: Natural History
  • Cardiovascular Diseases
  • Heart Diseases
  • Coronary Disease
  • Cerebrovascular Accident
  • Myocardial Infarction
  • Postmenopause
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
July 1995
 

No eligibility criteria

Male
 
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00005466
 
4910
National Heart, Lung, and Blood Institute (NHLBI)
 
 
National Heart, Lung, and Blood Institute (NHLBI)
May 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP