Completed

Postmenopausal Progestins, MI and Stroke

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What is being collected

Data Collection

Who is being recruted

Brain Diseases+13

+ Central Nervous System Diseases

+ Cerebrovascular Disorders

Until 100 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: April 1988
See protocol details

Summary

Principal SponsorUniversity of Washington
Last updated: February 10, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1988

Actual date on which the first participant was enrolled.

BACKGROUND: Post-menopausal women who use estrogens generally experience at once a reduced risk of coronary heart disease and, at the same time, an increased risk of endometrial cancer. In order to protect the endometrium from unopposed estrogens, many physicians now recommend the addition of a progestin during 10-13 days of the cycle. Progestins may be implicated in the increased risk of myocardial infarction in women on oral contraceptives. DESIGN NARRATIVE: This was a case-control study. The computerized files of the Group Health Cooperative (GHC) in Seattle were used to identify cases. All postmenopausal women, aged 40 to 79, were eligible as cases if, according to World Health Organization criteria, they presented with a fatal or non-fatal myocardial infarction. A random sample of women listed in the enrollment files at GHC served as a source of potential controls. Review of the out-patient medical records, performed by an assistant blind to case-control status ensured that all study subjects met the same criteria. Telephone interviews were used to obtain information about exposure to postmenopausal hormones as well as known risk factors. The computerized pharmacy records at GHC provided additional information about exposure. Frequency matching controlled for the potential confounding effects of age and year of presentation. Stratification and logistic regression were used in data analysis. The study was renewed in 1995 to make more precise some of the indeterminate findings related to current use, cumulative dose and duration of use but also to extend the assessment of the risk or benefit to incident strokes. The study ended in January, 1999.

NCT00005220
Principal SponsorUniversity of Washington
Last updated: February 10, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Until 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesCerebrovascular DisordersInfarctionIschemiaNecrosisNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial IschemiaCardiovascular DiseasesCoronary DiseaseHeart DiseasesMyocardial InfarctionStroke

Criteria

No eligibility criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers