Testosterone Therapy in Hypogonadal Men Treated With Opioids

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Hypogonadism

Clinical Trial Details

NCT number	NCT02433730
Study type	Interventional
Source	Odense University Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	May 1, 2015
Completion date	September 1, 2019

View Details

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