The effect of testosterone replacement in patients with hypogonadotroph hypogonadism due to opioid treatment for non-malignant disease

INTERVENTION: Trade Name: Nebido Product Name: Nebido Product Code: G03BA03 Pharmaceutical Form: Prolonged‐release suspension for injection INN or Proposed INN: placebo Other descriptive name: PLACEBO Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intramuscular use Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intramuscular use CONDITION: Male Hypogonadism ; MedDRA version: 17.1 Level: LLT Classification code 10021012 Term: Hypogonadotrophic hypogonadism System Organ Class: 100000004860 Therapeutic area: Diseases [C] ‐ Hormonal diseases [C19] PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of testosterone replacement therapy in men with OPIAD on body composition, the haemostatic system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids, sexual function and quality of life.; Primary end point(s): Primary endpoint:; • Lean body mass; Secondary Objective: NA Timepoint(s) of evaluation of this end point: 6 months SECONDARY OUTCOME: Secondary end point(s): Secondary endpoints: ; • Haemostatic status ; • Pulse pressure ; • 24 h blood pressure ; • Lipid profile ; • Waist ; • Body fat ; • Glucose tolerance (OGTT) ; • HOMA‐ IR ; • Liver fat content ; • ACTH test ; • Serum testosterone ; • Bone mineral density ; • Bone structure ; • Physical and muscle strength tests ; • Pain threshold and tolerance tests ; • Sexual function ; • Quality of life ; Timepoint(s) of evaluation of this end point: 6 months INCLUSION CRITERIA: Male patients aged 18‐59 years Treatment with opioid for >3 month, daily dose > 50‐100 mg (for conversion see Annex 1) Total testosterone < 10 nmol/l FSH/LH levels normal or below normal laboratory values. Normal Prolactin levels 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range