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Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism
Sponsor: Brigham and Women's Hospital
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).
Official title: Androgen Replacement to Improve Patient-Important Outcomes in Men With Opioid-Induced Hypogonadism
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2022-01-10
Completion Date
2027-12-30
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
Testosterone Undecanoate 250 MG/ML
Intramuscular administration at a dose of 750 mg at baseline, weeks 4, and week 14.
Placebo
Intramuscular administration of placebo at baseline, weeks 4, and week 14.
Locations (1)
Brigham and Women's Hospital
Boston, Massachusetts, United States