Target population: Male hypogonadism (testosterone deficiency) As end points Bone mineralisation Body composition Markers of insulin sensitivity and cardiovascular disease Lipid profile Hemoglobin concentration amd hematocrit MedDRA version: 14.1 Level: LLT Classification code 10067734 Term: Testosterone deficiency System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: Nebido
Product Name: testosterone undecanoate
Pharmaceutical Form: Injection
INN or Proposed INN: testosterone undecanoate
CAS Number: 5949-44-0
Other descriptive name: TESTOSTERONE UNDECY
Sponsors
RMC, Skåne University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria: • 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 0, 12 and 24 months;Main Objective: To investigate whethe rlong term complications of androgen deficiency can be prevented by testosterone treatment;Secondary Objective: No;Primary end point(s): HOMAIR | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Decrease in fat mass and increase in fat-free mass, measured by DEXA Components of the metabolic syndrome Waist circumference, HDL-cholesterol, glucose, triglycerides and blood-pressure. Sexual life score Quality of life Bone mineral density ;Timepoint(s) of evaluation of this end point: 0, 12 and 24 months | — |
Countries
Norway, Sweden
Contacts
Public ContactReproductive Medicine Centre
Skåne University Hospital
Outcome results
None listed