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Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy

NCT01201863 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-07-27

Study results available
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Summary

The purpose of this study was to address 3 short term objectives; (1) Determine the effects of physiologic testosterone (T) therapy on neurological function and functional independence following traumatic brain injury (TBI) in hypogonadal men during inpatient rehabilitation; (2) Document the natural history of neuroendocrine dysfunction and recovery in men during inpatient rehabilitation after TBI; (3) Obtain data to validate the NIH toolbox, a novel assessment of neurological function for use in the TBI population; and 2 long-term objectives: (1) Utilize study findings to design a multicenter trial to further assess the impact of T therapy in hypogonadal men following TBI and (2) Impact TBI practice management with new information about neuroendocrine dysfunction after TBI and hormone treatments to improve outcomes.

Conditions

  • Endocrine Dysfunction
  • Trauma
  • Brain Injury

Interventions

DRUG

Androgel (Testosterone Gel)

2.5 gram stickpacks administered with starting dosage of 5g increasing to a max of 10g.

OTHER

Placebo gel

2.5 gram stickpacks with starting dose of 5g increasing to max of 10g.

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • Craig Hospital

    lead OTHER

Principal Investigators

  • David Ripley, MD · Rehab Institute of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01201863 on ClinicalTrials.gov