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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by James J. Peters Veterans Affairs Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00398034
First received: November 8, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted

November 8, 2006
November 8, 2006
November 2006
Not Provided
• To determine if testosterone replacement can improve pain control in opioid-treated, hypogonadal men with chronic pain.
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-Treated Chronic Pain Patients: A Pilot Study.
Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-Treated Chronic Pain Patients: A Pilot Study.

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Pain
  • Hypogonadism
Drug: Testosterone Gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
62
October 2008
Not Provided

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.
Male
18 Years to 60 Years
No
Contact: David AN Siegel, M.D. 212-433-0606 david.siegel2@med.va.gov
United States
 
NCT00398034
2192-06-049
Not Provided
Not Provided
James J. Peters Veterans Affairs Medical Center
Solvay Pharmaceuticals
Principal Investigator: David AN Siegel, M.D. James J. Peters VAMC
James J. Peters Veterans Affairs Medical Center
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP