Androgen Replacement to Improve Patient-Important Outcomes in Men With Opioid-Induced Hypogonadism

What this Trial Is About

Researchers are evaluating the effects of testosterone replacement therapy on men aged 18 years or older who have chronic non-cancer spinal pain and opioid-induced hypogonadism due to long-term opioid use. The study aims to compare improvements in pain perception, pain tolerance, sexual function, fatigue, and quality of life between testosterone treatment and placebo. This trial is a randomized, double-blind, placebo-controlled Phase 2 study conducted at a single center. Participants receive either intramuscular injections of testosterone undecanoate at a dose of 750 mg or placebo injections. These doses are administered at baseline, week 4, and week 14 over a 6-month treatment period. The trial has two groups: one receiving testosterone and the other receiving placebo, with both groups masked to the treatment they receive. During the study, participants undergo regular assessments including the Pain Interference Subscale of the Brief Pain Inventory questionnaire at baseline, 3 months, and 6 months. They also have quantitative sensory testing for pain under various stimuli such as pressure, deep pressure, mechanical, heat, and cold at the same intervals. Brain connectivity is evaluated through imaging at baseline and 6 months. Researchers monitor safety, quality of life, and treatment adherence throughout the trial, which concludes after the 6-month treatment period.

Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism