Effects of testosterone on glycaemic control and other Cardiovascular Risk factors in Hypogonadal Men with uncontrolled Type 2 Diabetes: A randomized double – blinded placebo controlled add on trial using depot testosterone undecanoate” - Testosterone and glycaemic control in hypogonadal men. Version 1

Research and Development department0 个研究点开始时间: 2012年4月2日最近更新: 2012年4月24日

适应症

试验速览

暂无简介。

•1.Men with age >18 years
•2.Type 2 Diabetes mellitus
•3.HbA1C >7% <9.5%
•4.Confirmed hypogonadism (early morning [0800-1000 h] total testosterone [TT] =12 nmol/L or calculated free testosterone =255 pmol/L on two occasions =1 week apart), with at least two symptoms of hypogonadism
•5.Must be naïve to androgen replacement therapy
•6.If on replacement therapy for the hypopituitarism or multiple endocrine deficiencies, the subject must be on stable doses of thyroid hormone and adrenal replacement hormones for at least 14 days prior to the enrolment.
•7.No contraindication to the use of the study product – testosterone undecanoate
•8.Patients understands the study protocol and voluntarily agrees to participate by providing written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1.Inability to give informed consent
•2.Polycythaemia/ Haematocrit of >0.52
•3.Abnormal prostrate digital rectal examination( palpable nodule/s) or severe prostratism or elevated PSA
•4.History of prostrate cancer or breast cancer
•5.Patient is enrolled in another experimental trial which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial
•6.Patients with significant intercurrent disease like severe heart failure, kidney disease on dialysis, psychiatric illness or any other co-morbidities making them unable to attend the scheduled visits of the trial
•7.History of alcohol abuse or any drug abuse in the past 2 years
•8.Current use of antiandrogens, glucocorticoids ( except where used as replacement therapy), long acting opioid analgaesics( eg., methadone, buprenorphine), oestrogens, CYP3A4 inducers( eg., barbiturates) CYP3A4 inhibitors (eg., HIV antivirals, amiodarone, ketaconazole, ciprofloxacin, azithromycin etc)
•9. Men seeking to father a child and have not yet completed the family.

发起方

Research and Development department