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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:
ClinicalTrials.gov Identifier:
NCT01124773
First Posted: May 17, 2010
Last Update Posted: November 6, 2017
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 (Responsible Party):
Wake Forest University Health Sciences
May 13, 2010
May 17, 2010
November 6, 2017
June 2009
June 2016   (Final data collection date for primary outcome measure)
All-cause dementia and Mild Cognitive Impairment [ Time Frame: Measured once a year ]
Participants will have a cognitive assessment administered over the telephone.
All-cause dementia [ Time Frame: Measured once a year ]
One time per year, participants will have a cognitive assessment administered over the telephone.
Complete list of historical versions of study NCT01124773 on ClinicalTrials.gov Archive Site
Global and domain specific cognitive function. [ Time Frame: Measured once a year ]
Participants will have a cognitive assessment administered over the telephone.
Mild Cognitive Impairment [ Time Frame: 1 time per year ]
Once per year, participants will receive a cognitive assessment by telephone.
Not Provided
Not Provided
 
Memory Study of Youngest Women Enrolled in the Women's Health Initiative Hormone Therapy (HT) Arm
Women's Health Initiative Memory Study of Younger Women
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Women who enrolled into the HT arm of the Women's Health Initiative when age 50-54 at the time of randomization.
Dementia
Not Provided
Previous HT use and cognition
Women who were aged 50-54 at the time of randomization into the WHI hormone trials.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1362
June 2016
June 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be enrolled in the Women's Health Initiative Extension

Exclusion Criteria:

  • Not enrolled in the Women's Health Initiative Extension
Sexes Eligible for Study: Female
50 Years to 54 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01124773
699
Yes
Not Provided
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.
Wake Forest University Health Sciences
Wake Forest University Health Sciences
Not Provided
Principal Investigator: Stephen R Rapp, PhD Wake Forest University Health Sciences
Wake Forest University Health Sciences
March 2017