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

Primary Purpose

Pain, Hypogonadism

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Testosterone Gel
Sponsored by
James J. Peters Veterans Affairs Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring opioids, pain, hypogonadism, depression, fatigue, cognition, libido

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    • To determine if testosterone replacement can improve pain control in opioid-treated, hypogonadal men with chronic pain.

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    November 8, 2006
    Last Updated
    October 11, 2023
    Sponsor
    James J. Peters Veterans Affairs Medical Center
    Collaborators
    Solvay Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00398034
    Brief Title
    Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.
    Official Title
    Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2006
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The original PI (David Siegel) Left the VA
    Study Start Date
    October 30, 2006 (Actual)
    Primary Completion Date
    September 6, 2007 (Actual)
    Study Completion Date
    September 6, 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    James J. Peters Veterans Affairs Medical Center
    Collaborators
    Solvay Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Hypogonadism
    Keywords
    opioids, pain, hypogonadism, depression, fatigue, cognition, libido

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Testosterone Gel
    Primary Outcome Measure Information:
    Title
    • To determine if testosterone replacement can improve pain control in opioid-treated, hypogonadal men with chronic pain.
    Secondary Outcome Measure Information:
    Title
    In opioid-treated, hypogonadal men with chronic pain, to determine whether testosterone replacement therapy (TRT) will:
    Title
    reduce the opioid requirement.
    Title
    improve fatigue
    Title
    improve depression
    Title
    improve sexual function.
    Title
    Improve cognition
    Title
    To determine the proportion of responders to the analgesic effects of TRT

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christopher P Cardozo, M.D.
    Organizational Affiliation
    James J. Peters VAMC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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