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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000175
First Posted: November 1, 1999
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute on Aging (NIA)
  Purpose
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 Intervention
Cognition Disorders Mood Disorders Drug: Estrogen Drug: Testosterone

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment

Further study details as provided by National Institute on Aging (NIA):

Estimated Study Completion Date: June 2005
Estimated Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Adult, Senior)
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
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

Publications:
ClinicalTrials.gov Identifier: NCT00000175     History of Changes
Other Study ID Numbers: IA0016
First Submitted: October 29, 1999
First Posted: November 1, 1999
Last Update Posted: March 17, 2014
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