The Impact of Low Testosterone Levels on Men with Liver Failure, and the Efficacy of Testosterone Therapy
A randomised, double-blinded trial in men with cirrhosis of Testosterone therapy versus placebo to assess the impact on body composition
The University of Melbourne
100 participants
May 29, 2013
Interventional
Conditions
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
Eligibility
Inclusion Criteria1
- Men with cirrhosis with low baseline testosterone levels (<12nmol/L for total testosterone, or <230pmol/L for free testosterone)
Exclusion Criteria6
- 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
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Interventions
Intramuscular Testosterone therapy (Reandron 1000mg) for 12 months, delivered as per manufacturer's instructions at 0, 6, 18, 30, 42 and 54 weeks
Locations(1)
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ACTRN12614000526673