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

This study has been terminated.

First Received on October 29, 1999. Last Updated on December 10, 2009 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:	Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment

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):

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

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.

ClinicalTrials.gov Identifier:	NCT00000175 History of Changes
Other Study ID Numbers:	IA0016
Study First Received:	October 29, 1999
Last Updated:	December 10, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Emotions
Cognition
Aging
Memory

Additional relevant MeSH terms:

Cognition Disorders
Mood Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Estrogens

Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on February 12, 2012