Status:
WITHDRAWN
Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.
Lead Sponsor:
James J. Peters Veterans Affairs Medical Center
Collaborating Sponsors:
Solvay Pharmaceuticals
Conditions:
Pain
Hypogonadism
Eligibility:
MALE
18-60 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 30 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00398034
Start Date
October 30 2006
End Date
September 6 2007
Last Update
October 13 2023
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