Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
Condition: Endocrine Dysfunction; Trauma; Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Intervention: Androgel (Testosterone Gel); Placebo gel
Intervention description: 2.5 gram stickpacks administered with starting dosage of 5g increasing to a max of 10g.; 2.5 gram stickpacks with starting dose of 5g increasing to max of 10g.
Intervention MeSH terms: Testosterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: Male
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Testosterone; Traumatic Brain Injury; Hypogonadism; Endocrine Dysfunction; Low Testosterone in men with new Traumatic Brain Injury

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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

          2. 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;

          3. Continuously hospitalized from time of injury until admission for rehabilitation;

          4. Enrolled in study within 6 months of TBI;

          5. Receiving inpatient rehabilitation for TBI at Craig Hospital;

          6. Males between the ages of 16 to 65 (inclusive);

          7. Approval by attending physician;

          8. Testosterone level below the assay normal range;

          9. Consent to study participation

             Exclusion Criteria:

         10. History of any conditions that would prohibit testing contained in the NIH toolbox;

         11. Non-English or non-Spanish speaking (to the extent that would limit the ability to
             complete study measures);

         12. History of prior psychiatric illness requiring hospitalization;

         13. Prior testosterone therapy;

         14. History of or current or suspected hormonally dependent cancer , including carcinoma
             of the breast or prostate cancer;

         15. Known hypersensitivity to any T gel ingredients including alcohol and soy products;

         16. Hematocrit (HCT) greater than 55% (normal range in Colorado is up to 52) or
             transaminase elevation >4x upper limit of the normal range.

         17. Abnormal finding on digital rectal examination such as nodule, asymmetry, or
             induration (Does not include enlarged prostate or abnormal rectal tone)

         18. PSA>4.0

         19. BMI <16 or >40kg/m2

         20. History of untreated prolactinoma

         21. 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.