NCT02433730

Testosterone Therapy in Hypogonadal Men Treated With Opioids

The Effect of Testosterone Replacement in Patients With Hypogonadotrophic Hypogonadism Due to Opioid Treatment for Non-malignant Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Marianne Andersen · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypogonadism

Interventions

Type	Name	Description
DRUG	Testosterone	intramuscular injection
DRUG	placebo	intramuscular injection

Timeline

• Start date: 2015-05-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2015-05-05
• Last updated: 2020-09-16

Locations

1 site across 1 country: Denmark