NCT00000175

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 1999

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 1999

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

December 11, 2009

Status Verified

March 1, 2004

First QC Date

October 29, 1999

Last Update Submit

December 10, 2009

Conditions

Cognition DisordersMood Disorders

Keywords

EmotionsCognitionAgingMemory

Interventions

EstrogenDRUG
TestosteroneDRUG

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Women and men aged 65-90 who have not received hormone replacement for the last three months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gerontology Research Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

  • Henderson VW. The epidemiology of estrogen replacement therapy and Alzheimer's disease. Neurology. 1997 May;48(5 Suppl 7):S27-35. doi: 10.1212/wnl.48.5_suppl_7.27s.

    PMID: 9153164BACKGROUND

  • Janowsky JS, Oviatt SK, Orwoll ES. Testosterone influences spatial cognition in older men. Behav Neurosci. 1994 Apr;108(2):325-32. doi: 10.1037//0735-7044.108.2.325.

    PMID: 8037876BACKGROUND

  • Sherwin BB. Estrogen effects on cognition in menopausal women. Neurology. 1997 May;48(5 Suppl 7):S21-6. doi: 10.1212/wnl.48.5_suppl_7.21s.

    PMID: 9153163BACKGROUND

MeSH Terms

Conditions

Cognition DisordersMood Disorders

Interventions

EstrogensTestosterone

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal Hormones

Study Officials

  • Dr. Pauline Maki

    National Institute on Aging, Gerontology Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

October 29, 1999

First Posted

November 1, 1999

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

December 11, 2009

Record last verified: 2004-03

Locations

US(1)