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

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ClinicalTrials.gov Identifier: NCT00000175
Recruitment Status : Terminated
First Posted : November 1, 1999
Last Update Posted : December 11, 2009
Sponsor:
Information provided by:
National Institute on Aging (NIA)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cognition Disorders Mood Disorders Drug: Estrogen Drug: Testosterone Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Estimated Primary Completion Date : June 2005
Estimated Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000175


Locations
United States, Maryland
Gerontology Research Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
National Institute on Aging (NIA)
Investigators
Principal Investigator: Dr. Pauline Maki National Institute on Aging, Gerontology Research Center
More Information
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Publications:

ClinicalTrials.gov Identifier: NCT00000175     History of Changes
Other Study ID Numbers: IA0016
First Posted: November 1, 1999    Key Record Dates
Last Update Posted: December 11, 2009
Last Verified: March 2004

Keywords provided by National Institute on Aging (NIA):
Emotions
Cognition
Aging
Memory

Additional relevant MeSH terms:
Disease
Mood Disorders
Cognition Disorders
Pathologic Processes
Mental Disorders
Neurocognitive Disorders
 Testosterone
Estrogens
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs