Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351819
Status:
COMPLETED
Last Update Posted:
2017-06-28
First Post:
2006-07-12
Brief Title:
Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception in Men With Chronic Pain Syndrome
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAP
Brief 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 ngdl 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
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 ngdl 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None