Back to resultsThe Effects of Sex Hormones on Cognition and Mood in Older Adults
Primary Purpose
Cognition Disorders, Mood Disorders
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Estrogen
Testosterone
Sponsored by
About this trial
This is an interventional treatment trial for Cognition Disorders focused on measuring Emotions, Cognition, Aging, Memory
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.
Sites / Locations
- Gerontology Research Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000175
First Posted
October 29, 1999
Last Updated
December 10, 2009
Sponsor
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT00000175
Brief Title
The Effects of Sex Hormones on Cognition and Mood in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
March 2004
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
June 2005 (Anticipated)
Study Completion Date
June 2005 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Aging (NIA)
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognition Disorders, Mood Disorders
Keywords
Emotions, Cognition, Aging, Memory
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Estrogen
Intervention Type
Drug
Intervention Name(s)
Testosterone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Pauline Maki
Organizational Affiliation
National Institute on Aging, Gerontology Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gerontology Research Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9153164
Citation
Henderson VW. The epidemiology of estrogen replacement therapy and Alzheimer's disease. Neurology. 1997 May;48(5 Suppl 7):S27-35. doi: 10.1212/wnl.48.5_suppl_7.27s.
Results Reference
background
PubMed Identifier
8037876
Citation
Janowsky JS, Oviatt SK, Orwoll ES. Testosterone influences spatial cognition in older men. Behav Neurosci. 1994 Apr;108(2):325-32. doi: 10.1037//0735-7044.108.2.325.
Results Reference
background
PubMed Identifier
9153163
Citation
Sherwin BB. Estrogen effects on cognition in menopausal women. Neurology. 1997 May;48(5 Suppl 7):S21-6. doi: 10.1212/wnl.48.5_suppl_7.21s.
Results Reference
background
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The Effects of Sex Hormones on Cognition and Mood in Older Adults
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