Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.
WithdrawnPhase 2NCT00398034
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.
- Conditions
- Pain
- Hypogonadism
- Interventions
- Drug: Testosterone Gel
- Sponsor
- James J. Peters Veterans Affairs Medical Center
- Collaborators
- Solvay Pharmaceuticals
- Start date
- 2006-10-30
- Primary completion
- 2007-09-06
- Sex
- Male
- Age range
- from 18 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00398034