Effect of Testosterone Treatment on Mortality and Hospitalisation in Men with Liver Cirrhosis and low serum testosterone: A Randomized Controlled Trial

Austin Hospital0 sites250 target enrollmentJune 9, 2016

Overview

No summary available.

Registry

who.int

Start Date

June 9, 2016

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

Male

Sponsor

Austin Hospital

•Men with cirrhosis and low serum testosterone
•\-cirrhosis defined on clinical grounds, by a combination of clinical, biochemical and radiological features. In equivocal cases, a fibroscan reading of \>20kPa is required to avoid the inadvertent inclusion of non\-cirrhotics
•\-low serum testosterone requires 2 x morning blood samples that meet criteria: total T \<12nmol/L OR free T \<230pmol/

•1\)Prostate cancer, elevated PSA or abnormal prostate on digital rectal exam
•2\)Hepatocellular or other active cancer
•3\)Current or previous (within 12 months) testosterone or androgen deprivation therapy
•4\)Severe renal impairment (eGFR \<30ml/min)
•5\)Symptomatic ischaemia heart disease or significant heart failure symptoms (New York Heart Association class III or IV)
•6\)Uncontrolled hypertension \>160/100mHg
•7\)Uncontrolled obstructive sleep apnoea
•8\)Platelet count \<30 x 10^9 given the need for intramuscular drug administration
•9\)Other non\-liver disease thought to lead to death or severe debility within 2 years