Testosterone Therapy in Hypogonadal Men Treated With Opioids

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02433730
• Other study ID #: 22102014
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2015
• Est. completion date: September 1, 2019

Study information

• Verified date: September 2020
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Testosterone
intramuscular injection
• placebo
intramuscular injection

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odensen

Sponsors (1)

Lead Sponsor	Collaborator
Marianne Andersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lean body mass	dual xray absorptiometry scan	24 weeks