Testosterone Replacement in Non-alcoholic Steatohepatitis (TEREPINS)
Status:
Completed
Trial end date:
2017-01-30
Target enrollment:
Participant gender:
Summary
The main research questions are: In hypogonadal men with non-alcoholic steatohepatitis
(NASH), does Testosterone Replacement Therapy (TRT), given for 12 months
1. improve severity of steatosis on liver biopsy (Primary Question)?
2. improve severity of associated steatohepatitis on liver biopsy?
3. reduce liver fat content as assessed by proton Magnetic Resonance Spectroscopy (1H-MRS)?
The work proposed here is an open pilot study of 10 patients, the main aim of which is to
assess the effect size of TRT in regard to these end points (regarding which there are no
published data), thereby allowing power calculations for a more definitive phase II trial.
Other aims would be assessing recruitment and consent rates, which would also inform the
design of the larger study.