Testosterone Therapy in Hypogonadal Men Treated With Opioids

NCT02433730 | Completed Phase 4 DMC

• 1 other identifier: 22102014
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Hypogonadism

Outcome Measures

Primary Outcomes (1)

• lean body mass

  dual xray absorptiometry scan

  24 weeks

Study Arms (2)

placebo

ACTIVE COMPARATOR

intramuscular injection

Drug: placebo

testosterone

ACTIVE COMPARATOR

intramuscular injection

Drug: Testosterone

Interventions

Testosterone DRUG

intramuscular injection

Also known as: nebido

testosterone

placebo DRUG

intramuscular injection

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marianne Andersen: lead

Study Sites (1)

Odense University Hospital

Odensen, Denmark

Location

Related Publications (1)

• Olesen TB, Glintborg D, Johnk F, Olsen MH, Andersen MS. Blood pressure responses to testosterone therapy are amplified by hematocrit levels in opioid-induced androgen deficiency: a double-blind, randomized, placebo-controlled trial. J Hypertens. 2024 May 1;42(5):893-901. doi: 10.1097/HJH.0000000000003638. Epub 2023 Dec 13.

  PMID: 38088425 DERIVED

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone; testosterone undecanoate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD,

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: May 5, 2015
• Study Start: May 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

DK (1)