Testosterone Therapy in Hypogonadal Men Treated With Opioids

Phase 4

Completed

• Conditions: Hypogonadism
• Interventions: Drug: placebo; Drug: Testosterone

• Registration Number: NCT02433730
• Lead Sponsor: Marianne Andersen

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.

Study Timeline

• Study First Submitted: 2015-01-27
• Study First Submitted QC: 2015-04-29
• Study Start: 2015-05-01
• Study First Posted: 2015-05-05
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-15
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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
• Implantation of sustained action sex hormone in the last 12 months
• Use of oral, buccal or transdermal testosterone in the last two weeks
• Treatment with glucocorticoids > 5 mg/day or 5 alfa reductase inhibitors
• Hypersensitivity to Nebido

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
placebo	placebo	intramuscular injection
testosterone	Testosterone	intramuscular injection

Primary Outcome Measures

Name	Time	Method
lean body mass	24 weeks	dual xray absorptiometry scan

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odensen, Denmark