Male Hypogonadism MedDRA version: 17.1 Level: LLT Classification code 10021012 Term: Hypogonadotrophic hypogonadism System Organ Class: 100000004860
Conditions
Interventions
Trade Name: Nebido
Product Name: Nebido
Product Code: G03BA03
Pharmaceutical Form: Prolonged-release suspension for injection
INN or Pro
Sponsors
Odense University Hospital, department M
Odense University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Hematocrit > 54 % at screening PSA > 3 ng/ml. Routine blood sample values above range (TSH, ionized calcium, hemoglobin, liver- and kidney function tests) Severe organic or mental disease reasonably suspected from history and/or clinical examination Past or present breast or prostate cancer Past or present liver tumors or acute or chronic hepatic diseases Any current diagnosis of cancers Acute thrombotic or embolic diseases Previous VTE and Cerebrovascular disease Uncontrolled hypertension (SBP>160mmHg and/or DBP>100mmHg) despite adequate antihypertensive therapy Chronic debilitating disease (kidney failure, cirrhosis, HIV, COPD, heart failure or ischemic heart disease). Epilepsy or migraine not adequately controlled by therapy. Severe benign prostatic hypertrophy with IPSS symptom score above 19 (annex 2) Sleep apnea Any indication of drugs and/or alcohol abuse (>50 g alcohol a day) Implantation of a sustained-action sex hormone in the last 12 months Use of oral, buccal or transdermal testosterone therapy in the last 2 weeks before the first study medication, or intramuscular testosterone ester other than TU in the last 6 week, or TU injection in the last 6 months or use of androgens during the entire study period (except the study medication) Blood coagulation irregularities presenting an increased risk of bleeding after intramuscular injection Treatment with glucocorticoids >5mg/day and 5 alfa reductase inhibitors. Hypersensitivity to Nebido BMI>40 kg/m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Secondary Objective: NA; Primary end point(s): Primary endpoint: • Lean body mass ;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Denmark
Contacts
Public ContactDepartment og endocrinology M
Odense University Hospital
Outcome results
None listed