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

• Status: Unknown status
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: James J. Peters Veterans Affairs Medical Center
• Collaborator: Solvay Pharmaceuticals
• Treatments: Analgesics; Analgesics, Opioid; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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.