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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sally A. Shumaker, PhD, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:
NCT01124773
First received: May 13, 2010
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

WHIMS-Y will provide the WHI information on one of the most enduring negative consequences of postmenopausal HT; a relative deficit in cognitive function and an increased risk for clinically significant cognitive impairment that remain in the cohort after the cessation of study-prescribed HT.


Condition Intervention
All Cause Dementia
Drug: Prem-Pro

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 Wake Forest Baptist Health:

Primary Outcome Measures:
  • All-cause dementia [ Time Frame: Measured once a year ] [ Designated as safety issue: No ]
    One time per year, participants will have a cognitive assessment administered over the telephone.


Secondary Outcome Measures:
  • Mild Cognitive Impairment [ Time Frame: 1 time per year ] [ Designated as safety issue: No ]
    Once per year, participants will receive a cognitive assessment by telephone.


Estimated Enrollment: 2300
Study Start Date: June 2009
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Previous HT use and cognition Drug: Prem-Pro
Pill; daily dose
Other Name: Hormone Therapy

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 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
Genders 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 Baptist Health
Investigators
Principal Investigator: Sally A Shumaker, PhD Wake Forest School of Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sally A. Shumaker, PhD, Professor, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier: NCT01124773     History of Changes
Other Study ID Numbers: 699
Study First Received: May 13, 2010
Last Updated: February 13, 2013
Health Authority: United States: Federal Government

Keywords provided by Wake Forest Baptist Health:
cognition
memory
hormone therapy

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014