The effect of testosterone replacement threapy in men using opioids

Phase 1

• Conditions: Male Hypogonadism; MedDRA version: 17.1 Level: LLT Classification code 10021012 Term: Hypogonadotrophic hypogonadism System Organ Class: 100000004860; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2014-004729-42-DK
• Lead Sponsor: Odense University Hospital, department M

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-13
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Male patients aged 18-59 years
Treatment with opioid for >3 month, daily dose > 50-100 mg (for conversion see Annex 1)
Total testosterone < 10 nmol/l
FSH/LH levels normal or below normal laboratory values.
Normal Prolactin levels

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Hematocrit > 54 % at screening
PSA > 3 ng/ml.
Routine blood sample values above range (TSH, ionized calcium, hemoglobin, liver- and kidney function tests)
Severe organic or mental disease reasonably suspected from history and/or clinical examination
Past or present breast or prostate cancer
Past or present liver tumors or acute or chronic hepatic diseases
Any current diagnosis of cancers
Acute thrombotic or embolic diseases
Previous VTE and Cerebrovascular disease
Uncontrolled hypertension (SBP>160mmHg and/or DBP>100mmHg) despite adequate antihypertensive therapy
Chronic debilitating disease (kidney failure, cirrhosis, HIV, COPD, heart failure or ischemic heart disease).
Epilepsy or migraine not adequately controlled by therapy.
Severe benign prostatic hypertrophy with IPSS symptom score above 19 (annex 2)
Sleep apnea
Any indication of drugs and/or alcohol abuse (>50 g alcohol a day)
Implantation of a sustained-action sex hormone in the last 12 months
Use of oral, buccal or transdermal testosterone therapy in the last 2 weeks before the first study medication, or intramuscular testosterone ester other than TU in the last 6 week, or TU injection in the last 6 months or use of androgens during the entire study period (except the study medication)
Blood coagulation irregularities presenting an increased risk of bleeding after intramuscular injection
Treatment with glucocorticoids >5mg/day and 5 alfa reductase inhibitors.
Hypersensitivity to Nebido
BMI>40 kg/m2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified