Memory Study of Youngest Women Enrolled in the Women's Health Initiative Hormone Therapy (HT) Arm (WHIMS-Y)
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Purpose
WHIMS-Y will provide the WHI information on one of the most enduring negative consequences of postmenopausal HT; a relative deficit in cognitive function and an increased risk for clinically significant cognitive impairment that remain in the cohort after the cessation of study-prescribed HT.
| Condition | Intervention |
|---|---|
|
All Cause Dementia |
Drug: Prem-Pro |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Women's Health Initiative Memory Study of Younger Women |
- All-cause dementia [ Time Frame: Measured once a year ] [ Designated as safety issue: No ]One time per year, participants will have a cognitive assessment administered over the telephone.
- Mild Cognitive Impairment [ Time Frame: 1 time per year ] [ Designated as safety issue: No ]Once per year, participants will receive a cognitive assessment by telephone.
| Estimated Enrollment: | 2300 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Previous HT use and cognition |
Drug: Prem-Pro
Pill; daily dose
Other Name: Hormone Therapy
|
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 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.
Eligibility| Ages Eligible for Study: | 50 Years to 54 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Women who enrolled into the HT arm of the Women's Health Initiative when age 50-54 at the time of randomization.
Inclusion Criteria:
- Must be enrolled in the Women's Health Initiative Extension
Exclusion Criteria:
- Not enrolled in the Women's Health Initiative Extension
Contacts and Locations| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | Sally A Shumaker, PhD | Wake Forest University |
More Information
Publications:
| Responsible Party: | Sally A. Shumaker, PhD, Professor, Wake Forest University Baptist Medical Center |
| ClinicalTrials.gov Identifier: | NCT01124773 History of Changes |
| Other Study ID Numbers: | 699 |
| Study First Received: | May 13, 2010 |
| Last Updated: | February 13, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Wake Forest University Baptist Medical Center:
|
cognition memory hormone therapy |
Additional relevant MeSH terms:
|
Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013