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
  Purpose

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.


Condition Intervention Phase
Pain
Hypogonadism
Drug: Testosterone Gel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-Treated Chronic Pain Patients: A Pilot Study.

Resource links provided by NLM:


Further study details as provided by James J. Peters Veterans Affairs Medical Center:

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

Estimated Enrollment: 62
Study Start Date: November 2006
Estimated Study Completion Date: October 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398034

Contacts
Contact: David AN Siegel, M.D. 212-433-0606 david.siegel2@med.va.gov

Locations
United States, New York
James J. Peters VAMC Recruiting
Bronx, New York, United States, 10468
Contact: David AN Siegel, M.D.    212-433-0606    david.siegel2@med.va.gov   
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         
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
Solvay Pharmaceuticals
Investigators
Principal Investigator: David AN Siegel, M.D. James J. Peters VAMC
  More Information

Publications:
American Pain Society, Guidelines for the Management of Acute and Cancer Pain. 4 ed. 1999, Glenview, IL: American Pain Society.

ClinicalTrials.gov Identifier: NCT00398034     History of Changes
Other Study ID Numbers: 2192-06-049
Study First Received: November 8, 2006
Last Updated: November 8, 2006
Health Authority: United States: Federal Government

Keywords provided by James J. Peters Veterans Affairs Medical Center:
opioids
pain
hypogonadism
depression
fatigue
cognition
libido

Additional relevant MeSH terms:
Chronic Pain
Hypogonadism
Endocrine System Diseases
Gonadal Disorders
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Analgesics
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Central Nervous System Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014