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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:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 (IPD) Sharing Statement:
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 September 21, 2017