The Effects of Sex Hormones on Cognition and Mood in Olde... | NCT00000175

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

NCT00000175

Sponsor

National Institute on Aging (NIA)

Status

Terminated

Last Update Posted

Dec 11, 2009Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Cognition Disorders
Mood Disorders

Interventions

Estrogen
Testosterone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2004

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Jun 2005Estimated

Completion Date

Jun 2005Estimated

First Submitted Date

Oct 29, 1999

First Submission Date that Met QC Criteria

Oct 29, 1999

First Posted Date

Nov 1, 1999Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2009

Last Update Posted Date

Dec 11, 2009Estimated

Description Module

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.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

90 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr. Pauline Maki	National Institute on Aging, Gerontology Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gerontology Research Center		Baltimore	Maryland	21224	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9153164	Background	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.
8037876	Background	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.

ID	Term
D019965	Neurocognitive Disorders
D001523	Mental Disorders

ID	Term
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions

Name	Type	Description	Arm Group Labels	Other Names
Estrogen	Drug
Testosterone	Drug

ID	Term
D004967	Estrogens
D013739	Testosterone