Testosterone Therapy in Hypogonadal Men Treated With Opioids

September 15, 2020 updated by: Marianne Andersen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odensen, Denmark
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: QUADRUPLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lean body mass
Time Frame: 24 weeks
dual xray absorptiometry scan
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marianne Andersen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

January 27, 2015

First Submitted That Met QC Criteria

April 29, 2015

First Posted (Estimate)

May 5, 2015

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22102014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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