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

2192-06-049

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.

2006-10-30

2007-09-06

2007-09-06

Withdrawn

Early phase I

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-10-13