Memory Study of Youngest Women Enrolled in the Women's Health Initiative Hormone Therapy (HT) Arm
- Conditions
- Dementia
- Registration Number
- NCT01124773
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1362
- Must be enrolled in the Women's Health Initiative Extension
- Not enrolled in the Women's Health Initiative Extension
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All-cause dementia and Mild Cognitive Impairment Measured once a year Participants will have a cognitive assessment administered over the telephone.
- Secondary Outcome Measures
Name Time Method Global and domain specific cognitive function. Measured once a year Participants will have a cognitive assessment administered over the telephone.
Trial Locations
- Locations (1)
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States