Male sex hormone therapy to young males with hormone deficiency: 2 years, double-blind, placebo controlled study

Conditions: Target population: Male hypogonadism (testosterone deficiency)As end pointsBone mineralisationBody compositionMarkers of insulin sensitivity and cardiovascular diseaseLipid profileHemoglobin concentration amd hematocrit
MedDRA version: 14.0Level: LLTClassification code 10067734Term: Testosterone deficiencySystem Organ Class: 10014698 - Endocrine disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2011-004266-15-NO

Lead Sponsor: niversity Hospital of North Norway

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 160

Inclusion Criteria

•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

Exclusion Criteria

•PSA > upper reference levels (3 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 hip and/or 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;