MedTrace Logo

Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

NCT04798469 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-14

No results posted yet for this study

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).

Conditions

  • Opioid Use
  • Pain
  • Hypogonadism, Male

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.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Shehzad Basaria, MD · Brigham and Women's Hospital

  • Robert R Edwards, PhD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2027-09-30
Completion
2027-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04798469 on ClinicalTrials.gov