Background: Endocrinopathy, including hypogonadism, is common following traumatic brain injury (TBI). Prior evidence suggests hypogonadism is associated with poorer function.
Objective: Determine the feasibility, safety, and efficacy of testosterone (T) therapy in hypogonadal men following TBI in acute rehabilitation.
Design: Randomized, double blind, placebo-controlled pilot trial.
Setting: Inpatient rehabilitation brain injury unit.
Participants: Men ages 18 -65, post moderate to severe TBI receiving inpatient rehabilitation.
Interventions: Transdermal T gel or placebo.
Main outcome measures: Revised FIM™ score, strength, adverse events.
Results: Of 498 screened, 70 participants were enrolled, and 22 meeting all criteria were randomized into placebo (n = 10) or physiologic T therapy (n = 12). There was no significant difference between groups in rate of improvement on the FIM™ (intercepts t = -0.31, p = 0.7593, or slopes t = 0.61, p = 0.5472). The Treatment group demonstrated the greatest absolute improvement in FIM™ scores and grip strength compared to Placebo or Normal T groups. There was no difference in adverse events between groups. Percentage of time with agitation or aggression was highest in the Placebo group.
Conclusions: Although there were no significant differences in rates of recovery, treatment group subjects showed greater absolute functional and strength improvement compared to the Placebo or Normal T groups.
Keywords: Functional Independence Measure (FIM); TBI; Traumatic brain injury; aggression; agitation; function; hypogonadism; outcomes; randomized drug trial; strength; testosterone.