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

Austin Hospital0 个研究点目标入组 250 人开始时间: 2016年6月9日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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

发起方

Austin Hospital