drugset / Trial / NCT02433730

Testosterone Therapy in Hypogonadal Men Treated With Opioids

NCT02433730

Phase 4 Completed 40 enrolled Marianne Andersen
RandomizedSingle-groupQuadruple-blindTreatment

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

Timeline

Start
2015-05-01
Primary completion
2019-09-01
Completion
2019-09-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Testosterone Small molecule 1000 mg Intramuscular