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Women's Estrogen for Stroke Trial (WEST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00026039
First Posted: November 8, 2001
Last Update Posted: May 15, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)
  Purpose
To determine if estrogen hormone replacement therapy reduces the risk of stroke or death in postmenopausal women who have already had stroke or a transient ischemic attack (TIA).

Condition Intervention Phase
Stroke Drug: estrogen Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Study Start Date: December 1993
Detailed Description:

The researchers enrolled 664 postmenopausal women with an average age of 71 years who had experienced an ischemic stroke or a TIA within the previous 90 days. Ischemic strokes and TIAs result from blockages in the vessels that supply blood to the brain. Participants were given a number of initial assessments, including the NIH Stroke Scale (NIHSS) of neurological impairment and the Barthel index of functional ability in activities of daily living. In addition to the usual best care for patients who have had a stroke, women in the trial received either oral estrogen (estradiol 17-beta at the standard replacement dose of 1 mg daily) or a matching placebo. Patients were studied for an average of 2.8 years. They stopped receiving the estrogen or placebo if they had a stroke.

The researchers found that there was no significant difference in the incidence of stroke or death in the women who were randomly assigned to receive estrogen instead of placebo. However, they found that the incidence of death due to stroke was higher in the estrogen group and that the non-fatal strokes in that group were associated with slightly worse neurological and functional impairments at 1 month after stroke. The risk of stroke within the first 6 months after enrollment in the study was also higher among women in the estrogen group. There were no significant differences between treatment groups in the number of TIAs or non-fatal heart attacks. However, participants receiving estrogen were more likely to experience gynecologic complications, particularly vaginal bleeding.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026039


Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Ralph I. Horwitz, M.D. Yale University
  More Information

ClinicalTrials.gov Identifier: NCT00026039     History of Changes
Other Study ID Numbers: R01NS031251 ( U.S. NIH Grant/Contract )
First Submitted: November 7, 2001
First Posted: November 8, 2001
Last Update Posted: May 15, 2006
Last Verified: November 2005

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
stroke
estrogen

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs