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Memory Study of Youngest Women Enrolled in the Women's Health Initiative Hormone Therapy (HT) Arm (WHIMS-Y)
This study has been completed.
Sponsor:
Wake Forest University Health Sciences
Information provided by (Responsible Party):
Stephen R. Rapp, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT01124773
First received: May 13, 2010
Last updated: March 23, 2017
Last verified: March 2017
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Purpose
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.
| Condition |
|---|
| Dementia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Women's Health Initiative Memory Study of Younger Women |
Resource links provided by NLM:
Further study details as provided by Stephen R. Rapp, Wake Forest University Health Sciences:
Primary Outcome Measures:
- All-cause dementia and Mild Cognitive Impairment [ Time Frame: Measured once a year ]Participants will have a cognitive assessment administered over the telephone.
Secondary Outcome Measures:
- Global and domain specific cognitive function. [ Time Frame: Measured once a year ]Participants will have a cognitive assessment administered over the telephone.
| Enrollment: | 1362 |
| Study Start Date: | June 2009 |
| Study Completion Date: | June 2016 |
| Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Previous HT use and cognition
Women who were aged 50-54 at the time of randomization into the WHI hormone trials.
|
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.
Eligibility| Ages Eligible for Study: | 50 Years to 54 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
Women who enrolled into the HT arm of the Women's Health Initiative when age 50-54 at the time of randomization.
Criteria
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01124773
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124773
Locations
| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
| Principal Investigator: | Stephen R Rapp, PhD | Wake Forest University Health Sciences |
More Information
Publications:
| Responsible Party: | Stephen R. Rapp, Professor, Wake Forest University Health Sciences |
| ClinicalTrials.gov Identifier: | NCT01124773 History of Changes |
| Other Study ID Numbers: |
699 |
| Study First Received: | May 13, 2010 |
| Last Updated: | March 23, 2017 |
| Individual Participant Data | |
| Plan to Share IPD: | Yes |
| Plan Description: | WHIMS-Y will follow guidelines, methods and processes as set forth in the WHI 2015-2020 Data Sharing Plan. Limited data sets will be archived on the WHIMS-Y website. Accompanying the limited data sets, substantial electronic documentation will be provided in a standard format that is readable on a variety of platforms. Documentation will include data collection forms, a description of study protocol and procedures, description of all variable re-coding and a list of major study publications. These data will be available to users only under a data-sharing agreement that provides for: a commitment to using the data only for research purposes and not to identify any individual participant; a commitment to securing the data using appropriate computer technology; and a commitment to destroying or returning the data after analyses are completed. Data will be made available for timely release no later than the acceptance for publication of the main findings from the final dataset. |
Keywords provided by Stephen R. Rapp, Wake Forest University Health Sciences:
|
cognition memory hormone therapy |
Additional relevant MeSH terms:
|
Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders |
Mental Disorders Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017