The Effect of Testosterone Replacement in Patients With Hypogonadotrophic Hypogonadism Due to Opioid Treatment for Non-malignant Disease
Overview
- Phase
- Phase 4
- Intervention
- placebo
- Conditions
- Hypogonadism
- Sponsor
- Marianne Andersen
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- lean body mass
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy of testosterone replacement therapy in men with low testosterone due to opioid treatment on body composition, the haemostatic system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids, sexual function and quality of life.
Male patients on opioids for non-malignant diseases aged 18-59 years diagnosed with hypogonadotrophic hypogonadism, referred from day hospitals and outpatient populations. 40 patients are randomized to either testosterone undecanoate i.m. or placebo i.m., i.e. 20 patients per arm
A double blinded randomized placebo controlled trial
Detailed Description
The study duration is 24 weeks. Patients are treated with Testosterone Undecanoate 1000 mg/4 ml, intramuscular (i.m.) or placebo at 0, 6 and 18 weeks. Outcome measures will be evaluated at 0 and 14 weeks.
Investigators
Marianne Andersen
Professor, MD,
Odense University Hospital
Eligibility Criteria
Inclusion Criteria
- •Male patients 18-75 years
- •Treatment with opioid for \>3 months, daily dose \>50-100 mg
- •Total testosterone \< 12 mmol/L
- •Follicle Stimulating Hormone (FSH)/Luteinizing Hormone (LH) levels normal og below normal laboratory values
- •Normal prolactin levels
Exclusion Criteria
- •Hematocrit\> 54% at screening
- •Prostate Specific Antigen (PSA) \> 3 ng/ml
- •Severe organic and mental disease
- •current or present cancer diagnosis
- •Previous venous thrombotic embolism and cerebrovascular disease
- •Uncontrolled hypertension
- •Epilepsy or migraine not adequately controlled by therapy
- •Severe benign prostate hypertrophy with symptom score \>19
- •Sleep apnea
- •Alcohol or drug abuse
Arms & Interventions
placebo
intramuscular injection
Intervention: placebo
testosterone
intramuscular injection
Intervention: Testosterone
Outcomes
Primary Outcomes
lean body mass
Time Frame: 24 weeks
dual xray absorptiometry scan