Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-Treated Chronic Pain Patients: A Pilot Study.
Recruitment status was Recruiting
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-Treated Chronic Pain Patients: A Pilot Study.|
- • To determine if testosterone replacement can improve pain control in opioid-treated, hypogonadal men with chronic pain.
- In opioid-treated, hypogonadal men with chronic pain, to determine whether testosterone replacement therapy (TRT) will:
- reduce the opioid requirement.
- improve fatigue
- improve depression
- improve sexual function.
- Improve cognition
- To determine the proportion of responders to the analgesic effects of TRT
|Study Start Date:||November 2006|
|Estimated Study Completion Date:||October 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398034
|Contact: David AN Siegel, M.D.||firstname.lastname@example.org|
|United States, New York|
|James J. Peters VAMC||Recruiting|
|Bronx, New York, United States, 10468|
|Contact: David AN Siegel, M.D. 212-433-0606 email@example.com|
|Principal Investigator: David AN Siegel, M.D.|
|Sub-Investigator: Christopher Cardoza, M.D.|
|Sub-Investigator: William Bauman, M.D.|
|Sub-Investigator: Ann Spungen, Ed.D|
|Principal Investigator:||David AN Siegel, M.D.||James J. Peters VAMC|