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

Dementia Clinical Trial

— WHIMS-Y  

Official title:

Women's Health Initiative Memory Study of Younger Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01124773
• Other study ID #: 699
• Status: Completed
• Phase: N/A
• First received: May 13, 2010
• Last updated: November 2, 2017
• Start date: June 2009
• Est. completion date: June 2016

Study information

• Verified date: March 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1362
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 54 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Not enrolled in the Women's Health Initiative Extension

Related Conditions & MeSH terms

• Dementia

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause dementia and Mild Cognitive Impairment	Participants will have a cognitive assessment administered over the telephone.	Measured once a year
Secondary	Global and domain specific cognitive function.	Participants will have a cognitive assessment administered over the telephone.	Measured once a year