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

This study has been terminated.

First Received: October 29, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00000175

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:	Treatment, Double-Blind, Placebo Control, Crossover Assignment

Resource links provided by NLM:

MedlinePlus related topics: Memory

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

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

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

Ages Eligible for Study:	65 Years to 90 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Henderson VW. The epidemiology of estrogen replacement therapy and Alzheimer's disease. Neurology. 1997 May;48(5 Suppl 7):S27-35. Review.

Janowsky JS, Oviatt SK, Orwoll ES. Testosterone influences spatial cognition in older men. Behav Neurosci. 1994 Apr;108(2):325-32.

Sherwin BB. Estrogen effects on cognition in menopausal women. Neurology. 1997 May;48(5 Suppl 7):S21-6. Review.

Study ID Numbers:	IA0016
Study First Received:	October 29, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000175 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Emotions
Cognition
Aging
Memory

Additional relevant MeSH terms:

Estrogens
Disease
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Cognition Disorders
Pharmacologic Actions

Testosterone
Delirium, Dementia, Amnestic, Cognitive Disorders
Pathologic Processes
Mental Disorders
Mood Disorders
Androgens

ClinicalTrials.gov processed this record on November 09, 2009