Memory Study of Youngest Women Enrolled in the Women's Health Initiative Hormone Therapy (HT) Arm (WHIMS-Y)

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ClinicalTrials.gov Identifier: NCT01124773

Recruitment Status : Completed

First Posted : May 17, 2010

Last Update Posted : November 6, 2017

Sponsor:

Information provided by (Responsible Party):

Wake Forest University Health Sciences

Study Description

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.

Condition or disease
Dementia

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.

Study Design


Study Type :	Observational
Actual Enrollment :	1362 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Women's Health Initiative Memory Study of Younger Women
Study Start Date :	June 2009
Actual Primary Completion Date :	June 2016
Actual Study Completion Date :	June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia Hormones Memory Women's Health

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Previous HT use and cognition Women who were aged 50-54 at the time of randomization into the WHI hormone trials.

Outcome Measures

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.

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 of Results:

Espeland MA, Shumaker SA, Leng I, Manson JE, Brown CM, LeBlanc ES, Vaughan L, Robinson J, Rapp SR, Goveas JS, Wactawski-Wende J, Stefanick ML, Li W, Resnick SM; WHIMSY Study Group. Long-term effects on cognitive function of postmenopausal hormone therapy prescribed to women aged 50 to 55 years. JAMA Intern Med. 2013 Aug 12;173(15):1429-36.

Espeland MA, Rapp SR, Manson JE, Goveas JS, Shumaker SA, Hayden KM, Weitlauf JC, Gaussoin SA, Baker LD, Padula CB, Hou L, Resnick SM; WHIMSY and WHIMS-ECHO Study Groups. Long-term Effects on Cognitive Trajectories of Postmenopausal Hormone Therapy in Two Age Groups. J Gerontol A Biol Sci Med Sci. 2017 Jun 1;72(6):838-845. doi: 10.1093/gerona/glw156.

Other Publications:

Vaughan L, Espeland MA, Snively B, Shumaker SA, Rapp SR, Shupe J, Robinson JG, Sarto GE, Resnick SM; Women's Health Initiative Memory Study of Younger Women (WHIMS-Y) Study Group. The rationale, design, and baseline characteristics of the Women's Health Initiative Memory Study of Younger Women (WHIMS-Y). Brain Res. 2013 Jun 13;1514:3-11. doi: 10.1016/j.brainres.2013.03.047. Epub 2013 Apr 8.


Responsible Party:	Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:	NCT01124773 History of Changes
Other Study ID Numbers:	699
First Posted:	May 17, 2010 Key Record Dates
Last Update Posted:	November 6, 2017
Last Verified:	March 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 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

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