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

Phase 2

Withdrawn

• Conditions: Hypogonadism; Pain

• Registration Number: NCT00398034
• Lead Sponsor: James J. Peters Veterans Affairs Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-10-30
• Status Verified: 2006-11
• Study First Submitted: 2006-11-08
• Study First Submitted QC: 2006-11-08
• Study First Posted: 2006-11-10
• Primary Completion: 2007-09-06
• Study Completion: 2007-09-06
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
• To determine if testosterone replacement can improve pain control in opioid-treated, hypogonadal men with chronic pain.

Secondary Outcome Measures

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