Status:
COMPLETED
Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
Lead Sponsor:
Craig Hospital
Collaborating Sponsors:
University of Colorado, Denver
Conditions:
Endocrine Dysfunction
Trauma
Eligibility:
MALE
16-65 years
Phase:
PHASE4
Brief 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 traum...
Detailed Description
This randomized, double blind, placebo-controlled pilot study assessed the hormonal status of men on admission to an inpatient TBI rehabilitation program. 498 consecutively admitted men for TBI rehabi...
Eligibility Criteria
Inclusion
- History of TBI as defined as "damage to brain tissue caused by an external mechanical force as evidenced by loss of consciousness or post traumatic amnesia (PTA) due to brain trauma or by objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination;"82
- Moderate to severe TBI as indicated by a Glasgow Coma Scale (GCS) score of less than or equal to 12 at emergency department admission, or post traumatic amnesia (PTA) of greater than or equal to seven days post-injury, or radiographic evidence of intracranial injury;
- Continuously hospitalized from time of injury until admission for rehabilitation;
- Enrolled in study within 6 months of TBI;
- Receiving inpatient rehabilitation for TBI at Craig Hospital;
- Males between the ages of 16 to 65 (inclusive);
- Approval by attending physician;
- Testosterone level below the assay normal range;
- Consent to study participation
Exclusion
- History of any conditions that would prohibit testing contained in the NIH toolbox;
- Non-English or non-Spanish speaking (to the extent that would limit the ability to complete study measures);
- History of prior psychiatric illness requiring hospitalization;
- Prior testosterone therapy;
- History of or current or suspected hormonally dependent cancer , including carcinoma of the breast or prostate cancer;
- Known hypersensitivity to any T gel ingredients including alcohol and soy products;
- Hematocrit (HCT) greater than 55% (normal range in Colorado is up to 52) or transaminase elevation \>4x upper limit of the normal range.
- Abnormal finding on digital rectal examination such as nodule, asymmetry, or induration (Does not include enlarged prostate or abnormal rectal tone)
- PSA\>4.0
- BMI \<16 or \>40kg/m2
- History of untreated prolactinoma
- History of severe heart failure or uncontrolled medical problem that would interfere with the participant's safety in the study as determined by the investigator.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01201863
Start Date
September 1 2010
End Date
July 1 2014
Last Update
July 27 2021
Active Locations (1)
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1
Craig Hospital
Englewood, Colorado, United States, 80113