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Stroke and MI in Users of Estrogen/Progestogen

This study has been completed.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00005466
  Purpose

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.


Condition
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Cerebrovascular Accident
Myocardial Infarction
Postmenopause

MedlinePlus related topics:   Heart Attack    Heart Diseases   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:   August 1991
Estimated Study Completion Date:   July 1995

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 (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.

  Eligibility
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

No eligibility criteria

  Contacts and Locations

No Contacts or Locations Provided
  More Information


Publications:

Study ID Numbers:   4910
First Received:   May 25, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00005466
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Heart Diseases
Cerebral Infarction
Myocardial Ischemia
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders
Coronary Disease
Necrosis
Brain Ischemia
Brain Infarction
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 03, 2008




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