Testosterone treatment in men with liver disease

Phase 3

• Conditions: cirrhosis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; hypogonadism; Metabolic and Endocrine - Other endocrine disorders

• Registration Number: ACTRN12616000756426
• Lead Sponsor: Austin Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 250

Inclusion Criteria

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/

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified