RecruitingPhase 2NCT04798469

Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

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


Sponsor

Brigham and Women's Hospital

Enrollment

150 participants

Start Date

Jan 10, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Testosterone Undecanoate 250 MG/ML for people with hypogonadism, male, opioid use, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include men aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTestosterone Undecanoate 250 MG/ML

Intramuscular administration at a dose of 750 mg at baseline, weeks 4, and week 14.

DRUGPlacebo

Intramuscular administration of placebo at baseline, weeks 4, and week 14.


Locations(1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

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NCT04798469


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