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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00398034
• Other study ID #: 2192-06-049
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 30, 2006
• Est. completion date: September 6, 2007

Study information

• Verified date: November 2006
• Source: James J. Peters Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 6, 2007
• Est. primary completion date: September 6, 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Hypogonadism
• Pain

Intervention

Drug:
• Testosterone Gel

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
James J. Peters Veterans Affairs Medical Center	Solvay Pharmaceuticals

References & Publications (70)

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* Note: There are 70 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• To determine if testosterone replacement can improve pain control in opioid-treated, hypogonadal men with chronic pain.
Secondary	In opioid-treated, hypogonadal men with chronic pain, to determine whether testosterone replacement therapy (TRT) will:
Secondary	reduce the opioid requirement.
Secondary	improve fatigue
Secondary	improve depression
Secondary	improve sexual function.
Secondary	Improve cognition
Secondary	To determine the proportion of responders to the analgesic effects of TRT