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:

MedlinePlus related topics: Chronic Pain Depression Fatigue

Drug Information available for: Testosterone propionate Methyltestosterone Testosterone cypionate Testosterone Testosterone enanthate

U.S. FDA Resources

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

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

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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:

Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Analgesics
Analgesics, Opioid
Androgens
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 19, 2013

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