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

James J. Peters Veterans Affairs Medical Center

Status and phase

Withdrawn

Phase 2

Conditions

Hypogonadism

Pain

Treatments

Drug: Testosterone Gel

Study type

Interventional

Funder types

Other U.S. Federal agency

Industry

Identifiers

NCT00398034

2192-06-049

Details and patient eligibility

About

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.

Full 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.

Sex

Male

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.