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

Mood Disorders Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00000175
• Other study ID #: IA0016
• Status: Terminated
• Phase: N/A
• First received: October 29, 1999
• Last updated: December 10, 2009
• Est. completion date: June 2005

Study information

• Verified date: March 2004
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 90 Years

Eligibility

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.

Study Design

Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Disease
• Mood Disorders

Intervention

Drug:
• Estrogen

• Testosterone

Locations

Country	Name	City	State
United States	Gerontology Research Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

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

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