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NCT00351819 · ClinicalTrials.gov registry record · Phase 2
Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception
A Phase 2 study, sponsored by Boston University.
- Completed
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
NCT00351819 is a Phase 2 study that has completed, run by Boston University. The registered enrollment target is 84 participants.
The verdict
NCT00351819, a Phase 2 study, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
Study 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 prima
Interventions
- OTHER Placebo
- DRUG AndroGel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2006-04 |
| Est. Completion | 2012-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00351819
The ClinicalTrials.gov registry entry for NCT00351819 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University, which has 185 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00351819 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00351819 about?
NCT00351819 is a clinical study titled "Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception". 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 decreas...
What is the current status of trial NCT00351819?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2006-04. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00351819?
The interventions under investigation include: Placebo (OTHER), AndroGel (DRUG).
Who is sponsoring clinical trial NCT00351819?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
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