Testosterone Therapy in Hypogonadal Men Treated With Opioids
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|ClinicalTrials.gov Identifier: NCT02433730|
Recruitment Status : Recruiting
First Posted : May 5, 2015
Last Update Posted : April 4, 2018
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|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Active Comparator: placebo
Active Comparator: testosterone
Other Name: nebido
- lean body mass [ Time Frame: 24 weeks ]dual xray absorptiometry scan
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 ClinicalTrials.gov identifier (NCT number): NCT02433730
|Contact: Dorte Glintborg, PhD, DMSci||+45 firstname.lastname@example.org|
|Odense University Hospital||Recruiting|
|Contact: Marianne Andersen 65412502 email@example.com|
|Contact 65412502 firstname.lastname@example.org|