CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 84 enrolled
Drug / intervention
AndroGel +1 moredrug
Likely dose
AndroGel 5gfrom record
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Search/NCT00351819
NCT00351819Phase 2Completed

Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception in Men With Chronic Pain Syndrome

Boston University·interventional·Posted Jul 13, 2006·Updated Jun 28, 2017

In Brief

A Phase 2 clinical trial evaluating AndroGel and Placebo for Pain and Hypogonadism. Completed, enrolled 84 participants across 1 site.

Detailed Summary

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: 1. To evaluate the effects of testosterone replacement on pain sensitivity, pain tolerance, and pain modulation in men with opioid-induced hypogonadism. 2. To determine the effects of testosterone replacement on health-related quality of life. 3. To determine whether testosterone replacement in hypogonadal men induces changes in the dosage requirements of opioid medications for pain control. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Hypogonadism
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 13, 2006
Enrollment StartApr 1, 2006
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 20.0 years ago

Interventions

AndroGeldrug

5g gel, applied once daily to the upper arms, upper back or shoulders.

Placeboother

5g gel, applied once daily to the upper arms, upper back or shoulders.