Women's Health Initiative Memory Study of Younger Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,362
- Locations
- 1
- Primary Endpoint
- All-cause dementia and Mild Cognitive Impairment
Study Overview
Brief Summary
WHIMS-Y provides valuable information on the long-term effects on risk of cognitive impairment of hormone therapy in a subset of WHI participants in the WHI Hormone Trials. Following cessation of study-prescribed HT cognitive function and impairment were assessed.
Detailed Description
The Women's Health Initiative Memory Study of Younger Women (WHIMS-Y) is proposed to assess the long-term impact of random assignment to postmenopausal hormone therapy (equine estrogen alone or in combination with medroxyprogesterone versus placebo) among women who were aged 50-54 at the time of randomization into the WHI hormone trials. Secondary objectives relate to the consistency of any treatment effects across unopposed or opposed therapy and whether there exists evidence of graded relationships between cognitive effects and age of administration, years from menopause, and baseline risk factors for cognitive impairment.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to 54 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Must be enrolled in the Women's Health Initiative Extension
Exclusion Criteria
- •Not enrolled in the Women's Health Initiative Extension
Outcomes
Primary Outcomes
All-cause dementia and Mild Cognitive Impairment
Time Frame: Measured once a year
Participants will have a cognitive assessment administered over the telephone.
Secondary Outcomes
- Global and domain specific cognitive function.(Measured once a year)