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The Effects of Sex Hormones on Cognition and Mood in Older Adults

This study has been terminated.
Study NCT00000175.   Last updated on June 23, 2005.   Information provided by National Institute on Aging (NIA)

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Descriptive Information Fields
Brief Title  The Effects of Sex Hormones on Cognition and Mood in Older Adults
Official Title 
Brief Summary

This study is investigating the effects of hormone replacement therapy on memory, mental abilities and mood in older adults aged 65-90. During the nine month long study, men will take testosterone for three months and women will take estrogen for three months. At four points during the study (once every three months), participants will complete a test battery and have blood drawn.

Detailed Description

Double-blind, placebo-controlled, crossover study investigating the effects of estrogen replacement and testosterone replacement on cognition and mood in older adults. Women who have not had a hysterectomy will be given Prempro (estrogen with progesterone to protect the uterine lining), and hysterectomized women will be given Premarin (estrogen only).

Study Phase
Study Type  Interventional
Study Design  Treatment, Double-Blind, Placebo Control, Crossover Assignment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Cognition Disorders
Mood Disorders
Intervention  Drug: Estrogen
Drug: Testosterone
MEDLINE PMIDs 9153164,   8037876,   9153163
Links
Recruitment Information Fields
Recruitment Status  Terminated
Enrollment 
Start Date 
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • Women and men aged 65-90 who have not received hormone replacement for the last three months.

Exclusion Criteria:

  • Previous head injury with loss of consciousness for more than one hour.
  • Men with a history of prostate cancer.
  • Men on testosterone replacement within the past three months.
  • Women with a history of breast or uterine cancer.
  • Women on estrogen replacement within the past three months.
Gender Both
Ages 65 Years to 90 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00000175
Organization ID IA0016
Secondary IDs ††
Study Sponsor  National Institute on Aging (NIA)
Collaborators ††
Investigators 
Principal Investigator:     Dr. Pauline Maki     National Institute on Aging, Gerontology Research Center    
Information Provided By National Institute on Aging (NIA)
Verification Date March 2004
First Received Date  October 29, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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