At a glance
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Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
In Brief
A Phase 4 clinical trial evaluating Androgel (Testosterone Gel) and Placebo gel for Endocrine Dysfunction and 2 related conditions. Completed, enrolled 46 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.