Testosterone Therapy in Hypogonadal Men Treated With Opioids

• Sponsor: Marianne Andersen (Other)
• Overall Status: Completed
• CT.gov ID: NCT02433730
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 52
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hypogonadism	Drug: Testosterone; Drug: placebo	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Testosterone Replacement in Patients With Hypogonadotrophic Hypogonadism Due to Opioid Treatment for Non-malignant Disease
• Actual Study Start Date: May 1, 2015
• Actual Primary Completion Date: Sep 1, 2019
• Actual Study Completion Date: Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: placebo intramuscular injection	Drug: placebo; intramuscular injection
Active Comparator: testosterone intramuscular injection	Drug: Testosterone; intramuscular injection; Other Names: nebido

Outcome Measures

Primary Outcome Measures

1. lean body mass [24 weeks]

   dual xray absorptiometry scan

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Odense University Hospital	Odensen		Denmark

Sponsors and Collaborators

• Marianne Andersen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marianne Andersen, Professor, MD,, Odense University Hospital
• ClinicalTrials.gov Identifier: NCT02433730
• Other Study ID Numbers: 22102014
• First Posted: May 5, 2015
• Last Update Posted: Sep 16, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Hypogonadism; Testosterone

Study Results

No Results Posted as of Sep 16, 2020