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| Sponsor: | Boston University |
|---|---|
| Information provided by: | Boston University |
| ClinicalTrials.gov Identifier: | NCT00351819 |
Purpose
Naturally occurring opiates (endorphins) decrease testosterone levels by inhibiting the synthesis of gonadotropin releasing hormone (GnRH) and also inhibiting testosterone synthesis by the testes. Similarly, men with addiction to narcotics and those on exogenous opioids for pain control have decreased serum testosterone levels. Indeed, these men complain of decreased libido, erectile dysfunction and impaired quality of life. Animal studies have shown that gonadectomy results in a decrease in pain threshold in rats and repletion of testosterone elevates that threshold. These observations suggest that testosterone may possess analgesic properties. Hence, the investigators hypothesize that hypogonadism developing in men on opioids results in an increased sensitivity to pain and requirement of higher doses of opioids. In this study, the investigators plan to administer testosterone to men with opioid-induced hypogonadism and evaluate their pain perception, pain sensitivity in response to noxious stimuli and changes in the requirement of opioids in response to testosterone administration.
Hypothesis:
Testosterone replacement in men with opioid-induced hypogonadism will improve pain tolerance, pain perception and quality of life.
Specific aims:
To accomplish our specific aims, the investigators propose a randomized, double blind, placebo-controlled, parallel arm study in which hypogonadal men with non-cancer chronic back pain syndrome on chronic opioids and low testosterone levels (<300 ng/dl) will be randomized to exogenous testosterone replacement therapy vs placebo. Our primary outcome is change in pain tolerance using various external painful stimuli. Secondary outcomes are change in pain sensitivity and modulation, quality of life and opioid requirements.
| Condition | Intervention |
|---|---|
|
Pain Hypogonadism |
Drug: Androgel (testosterone gel) Other: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception in Men With Chronic Pain Syndrome |
| Estimated Enrollment: | 84 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Androgel (testosterone gel)
Testosterone replacement therapy
|
Drug: Androgel (testosterone gel)
5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|
Placebo Comparator: Placebo
Placebo gel
|
Other: Placebo
5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kjersten Teeter, BS | 617-414-2936 | kjersten.teeter@bmc.org |
| United States, Massachusetts | |
| Boston University Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Principal Investigator: | Shehzad Basaria, MD | Boston University |
More Information
| Responsible Party: | Shehzad Basaria, Boston University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00351819 History of Changes |
| Other Study ID Numbers: | H-27995 |
| Study First Received: | July 12, 2006 |
| Last Updated: | March 29, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Testosterone Pain Opioid Hypogonadism |
|
Hypogonadism Gonadal Disorders Endocrine System Diseases Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone Androgens |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anabolic Agents |