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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02433730

Enrollment

Registered

2015-05-05

Start date

2015-05-01

Completion date

2019-09-01

Last updated

2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism

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.

Interventions

DRUGTestosterone

intramuscular injection

DRUGplacebo

intramuscular injection

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
lean body mass	24 weeks	dual xray absorptiometry scan

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026