None listed
Conditions
Brief summary
BRIEF BACKGROUND SUMMARY 1. Low serum testosterone levels are common in men with advanced liver disease 2. Symptoms and signs of testosterone deficiency are common in men with advanced liver disease 3. Low testosterone levels correlate with increased mortality in men with advanced liver disease HYPOTHESES 1. Testosterone therapy is not associated with significant adverse outcome in men with advanced liver disease 2. Testosterone treatment will increase muscle mass and bone mineral density in men with advanced liver disease SPECIFIC AIMS To conduct a single centre randomised controlled trial to assess the efficacy of 12 months of testosterone therapy in men with advanced liver disease and low serum testosterone
Interventions
Intramuscular Testosterone therapy (Reandron 1000mg) for 12 months, delivered as per manufacturer's instructions at 0, 6, 18, 30, 42 and 54 weeks
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Men with cirrhosis with low baseline testosterone levels (<12nmol/L for total testosterone, or <230pmol/L for free testosterone)
Exclusion criteria
Cancer - in particular screening must be performed for hepatocellular carcinoma and prostate cancer prior to trial entry Elevated PSA Severe renal or cardiac failure Sleep apnea requiring CPAP Polycythaemia Platelets below 30 x 10^6
Outcome results
None listed