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

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

50 year–54 year

Sex eligibility

Female

Study type

Observational

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Must be enrolled in the Women's Health Initiative Extension

Exclusion criteria

Not enrolled in the Women's Health Initiative Extension

Treatment and study plan

Primary outcomes

All-cause dementia and Mild Cognitive Impairment

Time frame: Measured once a year

Participants will have a cognitive assessment administered over the telephone.

Secondary outcomes

Global and domain specific cognitive function.

Time frame: Measured once a year

Participants will have a cognitive assessment administered over the telephone.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Women's Health Initiative Memory Study of Younger Women

Acronym: WHIMS-Y

Important dates

Study start: 2009
Primary completion: 2016
Study completion: 2016
First posted: May 17, 2010
Registry last updated: Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed