@article{ref1,
title="Testosterone replacement in hypogonadal men during inpatient rehabilitation following traumatic brain injury: results from a double-blind, placebo-controlled clinical pilot study",
journal="NeuroRehabilitation",
year="2020",
author="Ripley, David L. and Gerber, Don and Pretz, Christopher and Weintraub, Alan H. and Wierman, Margaret E.",
volume="ePub",
number="ePub",
pages="ePub-ePub",
abstract="BACKGROUND: Endocrinopathy, including hypogonadism, is common following traumatic brain injury (TBI). Prior evidence suggests hypogonadism is associated with poorer function. <br><br>OBJECTIVE: Determine the feasibility, safety, and efficacy of testosterone (T) therapy in hypogonadal men following TBI in acute rehabilitation. <br><br>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. <br><br>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, 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. <br><br>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. CLINICAL TRIAL REGISTRATION: Registered on ClinicalTrials.gov #NCT01201863.<p /> <p>Language: en</p>",
language="en",
issn="1053-8135",
doi="10.3233/NRE-192992",
url="http://dx.doi.org/10.3233/NRE-192992"
}