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Completed

NCT Number: NCT02433730

Testosterone Therapy in Hypogonadal Men Treated With Opioids

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

Completed

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Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Odense University Hospital

Odensen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testosterone

Drug

intramuscular injection

Other names: nebido

Placebo

Drug

intramuscular injection

Primary outcomes

  1. lean body mass

    Time frame: 24 weeks

    dual xray absorptiometry scan

Sponsors and collaborators

Lead sponsor

Marianne Andersen

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 5, 2015
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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