NCT04798469

Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this trial is to evaluate whether testosterone replacement results in greater improvement in pain perception, pain tolerance, sexual function, fatigue, and quality of life when compared with placebo in men with chronic spinal pain treated with opioids who have opioid-induced hypogonadism (low testosterone).

Detailed description

This single-center, randomized, double-blind, placebo-controlled, parallel-group trial will evaluate pain and quality of life outcomes associated with 6 months of treatment with testosterone or placebo in men aged 18 years or older with chronic non-cancer spinal pain who are taking opioid analgesics for at least 6 months and have opioid-induced hypogonadism.

Conditions

• Opioid Use
• Pain
• Hypogonadism, Male

Interventions

Type	Name	Description
DRUG	Testosterone Undecanoate 250 MG/ML	Intramuscular administration at a dose of 750 mg at baseline, weeks 4, and week 14.
DRUG	Placebo	Intramuscular administration of placebo at baseline, weeks 4, and week 14.

Timeline

• Start date: 2022-01-10
• Primary completion: 2027-09-30
• Completion: 2027-12-30
• First posted: 2021-03-15
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study