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RECRUITING
NCT04798469
PHASE2

Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States