Text Size

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
History of Changes

May 13, 2010
February 13, 2013
June 2009
May 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01124773 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Memory Study of Youngest Women Enrolled in the Women's Health Initiative Hormone Therapy (HT) Arm
Women's Health Initiative Memory Study of Younger Women

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Women who enrolled into the HT arm of the Women's Health Initiative when age 50-54 at the time of randomization.
All Cause Dementia
Drug: Prem-Pro
Pill; daily dose
Other Name: Hormone Therapy
Previous HT use and cognition
Intervention: Drug: Prem-Pro
Shumaker SA, Legault C, Kuller L, Rapp SR, Thal L, Lane DS, Fillit H, Stefanick ML, Hendrix SL, Lewis CE, Masaki K, Coker LH; Women's Health Initiative Memory Study. Conjugated equine estrogens and incidence of probable dementia and mild cognitive impairment in postmenopausal women: Women's Health Initiative Memory Study. JAMA. 2004 Jun 23;291(24):2947-58.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2300
May 2016
May 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Not enrolled in the Women's Health Initiative Extension
Female
50 Years to 54 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01124773
699
Yes
Sally A. Shumaker, PhD, Wake Forest University Baptist Medical Center
Wake Forest University Baptist Medical Center
Not Provided
Principal Investigator: Sally A Shumaker, PhD Wake Forest University
Wake Forest University Baptist Medical Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP