Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.

Study Overview
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Brief Summary
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The purpose of this pilot study is to test the effects of testosterone replacement on pain, fatigue, mood, cognition and libido in hypogonadal men on long-term opioid therapy for chronic pain.

Detailed Description
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Opioids are increasingly used for the treatment of non-malignant chronic pain with as many as five to ten million patients treated at the time of the most recent estimate in 2002. The side effects of opioids such as fatigue, loss of libido, Impaired cognition and sexual dysfunction have long been recognize and strikingly, resemble symptoms of hypogonadism in men. Many studies have demonstrated a high prevalence of hypogonadism in male subjects who are long-term users of opioids. The aims of this pilot study are, in hypogonadal men being treated with opioids for chronic pain, to: 1) determine the effect of TRT on pain; 2) determine effects of TRT on fatigue; 3) determine the effect of TRT on mood; 4) determine effects of TRT on cognition and 5) characterize the effects of TRT on sexual dysfunction. This study is a randomized, placebo-controlled, 6-week pilot study.

Official Title
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Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.

Conditions
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Pain, Hypogonadism

Intervention / Treatment
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* Drug: Testosterone Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male patients (above 18 years old and below 60 years old) Receiving greater than 20 IV morphine equivalents/day with <20% change in dosage in the last month. AM total testosterone <300 ng/dL Report worst pain during the past week grater than 4 on an 11-point numeric scale. Exclusion Criteria: Females Poorly controlled, symptomatic, active medical or psychiatric problems (e.g., HIV, hepatitis, diabetes, cancer, benign prostatic hypertrophy, substance abuse, major depression) Neurological or psychiatric disorder that would compromise the patient's ability to give informed consent or adhere to the requirements of the protocol. History of prostate cancer, abnormal findings on digital rectal exam, or PSA greater than 4.0 ng/m History of polycythemia Renal or hepatic dysfunction Hematocrit >55% Known history of hypersensitivity to transdermal testosterone gel. Abnormalities during digital rectal exam.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Testosterone Gel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • To determine if testosterone replacement can improve pain control in opioid-treated, hypogonadal men with chronic pain. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In opioid-treated, hypogonadal men with chronic pain, to determine whether testosterone replacement therapy (TRT) will: |  |  | 
| reduce the opioid requirement. |  |  | 
| improve fatigue |  |  | 
| improve depression |  |  | 
| improve sexual function. |  |  | 
| Improve cognition |  |  | 
| To determine the proportion of responders to the analgesic effects of TRT |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioids, pain, hypogonadism, depression, fatigue, cognition, libido