Androgen replacement in young hypogonadal men: a 2 year randomized, double-blind placebo controlled study - Testosterone replacement

RMC, Skåne University Hospital0 个研究点目标入组 160 人开始时间: 2011年10月25日最近更新: 2012年7月31日

适应症

试验速览

暂无简介。

•Men 18 to 50 years old, recruited through University Hospitals in Tromsö, Norway and Malmö, Sweden
•1.Previously treated for childhood cancer or testicular cancer, or
•2.Has completed infertility treatment and has sperm concentration below 20 x 106/mL
•Last cancer treatment >24 months ago.
•Total testosterone below 10 nmol/L and/or LH above 10 IU/L in two repeated samples drawn between 08.00 and 10.00.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 160
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•PSA > upper reference levels (2 pg/L).
•Untreated hypothyreoidism
•Use of statins, antihypertensive or anti-diabetic medication.
•Androgen replacement given within last 6 months prior to inclusion;
•Osteoporosis defined as DEXA L2-L4 t-score below -2.5 ;
•Men wishing or trying to become fathers in the near future (2 year) – for subfertle men the infertility treatment has to be completed at the time of inclusion.;
•Allergy to testosterone undecanoate or any other components of Nebido®;
•Previous or current prostate, breast or liver cancer;
•Sleep apnoea;
•acquired or inherited blood clotting irregularities;
•severe cardiac, hepatic or renal insufficiency or ischemic heart disease;

发起方

RMC, Skåne University Hospital