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Testosterone Therapy in Hypogonadal Men Treated With Opioids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02433730
Recruitment Status : Unknown
Verified April 2018 by Marianne Andersen, Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : May 5, 2015
Last Update Posted : April 4, 2018
Information provided by (Responsible Party):
Marianne Andersen, Odense University Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : May 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: placebo
intramuscular injection
Drug: placebo
intramuscular injection

Active Comparator: testosterone
intramuscular injection
Drug: Testosterone
intramuscular injection
Other Name: nebido

Primary Outcome Measures :
  1. lean body mass [ Time Frame: 24 weeks ]
    dual xray absorptiometry scan

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02433730

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Contact: Dorte Glintborg, PhD, DMSci +45 65412502

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Odense University Hospital Recruiting
Odensen, Denmark
Contact: Marianne Andersen    65412502   
Contact    65412502   
Sponsors and Collaborators
Marianne Andersen
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Responsible Party: Marianne Andersen, Professor, MD,, Odense University Hospital Identifier: NCT02433730    
Other Study ID Numbers: 22102014
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Gonadal Disorders
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs