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Testosterone Therapy in Hypogonadal Men Treated With Opioids

Primary Purpose

Hypogonadism

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Testosterone
placebo
Sponsored by
Marianne Andersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

placebo

testosterone

Arm Description

intramuscular injection

intramuscular injection

Outcomes

Primary Outcome Measures

lean body mass
dual xray absorptiometry scan

Secondary Outcome Measures

Full Information

First Posted
January 27, 2015
Last Updated
September 15, 2020
Sponsor
Marianne Andersen
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1. Study Identification

Unique Protocol Identification Number
NCT02433730
Brief Title
Testosterone Therapy in Hypogonadal Men Treated With Opioids
Official Title
The Effect of Testosterone Replacement in Patients With Hypogonadotrophic Hypogonadism Due to Opioid Treatment for Non-malignant Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marianne Andersen

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Active Comparator
Arm Description
intramuscular injection
Arm Title
testosterone
Arm Type
Active Comparator
Arm Description
intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Testosterone
Other Intervention Name(s)
nebido
Intervention Description
intramuscular injection
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
intramuscular injection
Primary Outcome Measure Information:
Title
lean body mass
Description
dual xray absorptiometry scan
Time Frame
24 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Odense University Hospital
City
Odensen
Country
Denmark

12. IPD Sharing Statement

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Testosterone Therapy in Hypogonadal Men Treated With Opioids

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