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

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.

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.