NCT00336726

Brief Summary

Traumatic Brain Injury (TBI) is a neurologic disorder cuased by physical trauma to the brain. Neuroendocrine abnormalities in these patients have been reported, including central hypogonadism within hours of the insult and eventual recovery of the hypothalamic-pituitary-gonadal axis with recovery of cognitive function to baseline. This pilot study will measure hormonal level of neuroendocine function at the time of TBI and various time points during recovery.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2006

Completed
Last Updated

March 24, 2011

Status Verified

December 1, 2004

First QC Date

June 13, 2006

Last Update Submit

March 23, 2011

Conditions

Eligibility Criteria

Age21 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Male subjects having had a recent traumatic brain injury

You may qualify if:

  • Male subjects having had a recent traumatic brain injury.

You may not qualify if:

  • Currently receivng sex steroids, glucocorticoids, or have an inability to complete the neurobehavioral assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Margaret E Wierman, MD

    Dept. of Veterans Affairs/University of Colorado HSC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 13, 2006

First Posted

June 14, 2006

Last Updated

March 24, 2011

Record last verified: 2004-12