Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

{ "Testosterone for Opioid-Induced Low Testosterone and Pain", "This study is looking at whether testosterone replacement can help men who have chronic (long-lasting) spinal pain, are taking opioid pain medications, and have opioid-induced hypogonadism (low testosterone). You might be able to join if you are a man aged 18 or older with chronic non-cancer spinal pain, have been using opioid pain relievers for at least six months, and have low testosterone levels. Participants will receive either Testosterone Undecanoate or a placebo (an inactive substance) as an injection. The main goal is to see if testosterone improves your pain, sexual function, fatigue, and overall quality of life. The study plans to enroll 150 participants.", "design": "This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either the active drug or a placebo, and neither you nor your doctor will know which you are receiving. It is a single-center study.", "commitments": "You would receive intramuscular injections at the start of the study, at week 4, and at week 14. Your pain levels will be assessed at the start of the study, at 3 months, and at 6 months.", "compensation": "Not stated in the trial record.", "follow_up": "Your pain levels will be assessed for up to 6 months after the start of treatment.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT04798469

Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

Recruiting
PHASE2Ages 18+InterventionalTreatment
Brigham and Women's Hospital
~150 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:Testosterone Undecanoate 250 MG/MLPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire
Measured over Baseline, 3 months, and 6 months
Opioid Use
Pain
Hypogonadism, Male
1 sites across 1 states
Massachusetts1
  • Shehzad Basaria, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital
  • Robert R Edwards, PhD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

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Eligibility criteria

Inclusion

Men, age 18 years and older.
Chronic non-cancer spinal pain.
Use of opioid analgesics for at least 6 months.
Serum total testosterone (measured by mass spectrometry) \<348 ng/dL and/or free testosterone \<70 pg/mL.
Ability and willingness to provide informed consent.

Exclusion

History of prostate cancer or breast cancer.
Known history of organic hypogonadism (e.g., due to hypothalamic, pituitary or testicular disease).
Use of testosterone within the past 6 months.
Baseline hematocrit \>48%.
Prostate-specific antigen (PSA) level \>4 ng/mL in Caucasians or \>3 ng/mL in African-Americans.
Presence of prostate nodule or induration on digital rectal examination.
Uncontrolled congestive heart failure.
Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within 3 months.
Serum creatinine \>2.5 mg/dL.
Alanine aminotransferase (ALT) level 3 times above the upper limit of normal.
Diagnosis of bipolar disorder or schizophrenia.
Presence of metallic implants (pacemakers, aneurysm clips, etc.) that preclude the patient from undergoing functional magnetic resonance imaging (MRI). In subjects who are otherwise eligible and either do not qualify for MRI or are reluctant to undergo imaging, the investigators may consider enrolling such participants on a case-by-case basis.
  • Changes in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaireBaseline, 3 months, and 6 months

    The Pain Interference Subscale of the BPI is specifically relevant to patients with chronic back pain who are using opioids and correlates strongly with the patient's quality of life.