Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT04798469

Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

Led by Brigham and Women's Hospital · Updated on 2026-04-14

150

Participants Needed

1

Research Sites

311 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Men, age 18 years and older
  • Chronic non-cancer spinal pain
  • Use of opioid analgesics for at least 6 months
  • Serum total testosterone less than 348 ng/dL and/or free testosterone less than 70 pg/mL
  • Ability and willingness to provide informed consent
Not Eligible

You will not qualify if you...

  • History of prostate cancer or breast cancer
  • Known organic hypogonadism due to hypothalamic, pituitary, or testicular disease
  • Use of testosterone within the past 6 months
  • Baseline hematocrit greater than 48%
  • Prostate-specific antigen level over 4 ng/mL in Caucasians or over 3 ng/mL in African-Americans
  • Presence of prostate nodule or induration on digital rectal exam
  • Uncontrolled congestive heart failure
  • Recent myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke within 3 months
  • Serum creatinine over 2.5 mg/dL
  • Alanine aminotransferase level 3 times above normal
  • Diagnosis of bipolar disorder or schizophrenia
  • Presence of metallic implants that prevent functional MRI, unless case-by-case approval is given

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

J

Julia Crosby

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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