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

NCT ID: NCT01124773

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1362 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dementia

Keywords

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cognition memory hormone therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Previous HT use and cognition

Women who were aged 50-54 at the time of randomization into the WHI hormone trials.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not enrolled in the Women's Health Initiative Extension
Minimum Eligible Age

50 Years

Maximum Eligible Age

54 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen R Rapp, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23578696 (View on PubMed)

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. doi: 10.1001/jamainternmed.2013.7727.

Reference Type RESULT
PMID: 23797469 (View on PubMed)

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.

Reference Type RESULT
PMID: 27506836 (View on PubMed)

Gaussoin SA, Espeland MA, Beavers DP, Casanova R, Garcia KR, Snively BM, Shumaker SA, Wallace RB, Rapp SR. Dementia outcomes after addition of proxy-based assessments for deceased or proxy-dependent participants. Int J Geriatr Psychiatry. 2019 Oct;34(10):1403-1411. doi: 10.1002/gps.5130. Epub 2019 May 23.

Reference Type DERIVED
PMID: 31034676 (View on PubMed)

Other Identifiers

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699

Identifier Type: -

Identifier Source: org_study_id