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Taking people in United StatesPhase 2

Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

Key facts

Who runs it
Brigham and Women's Hospital
Where
Boston, United StatesSee the site
Trial code
Status
Recruiting
Phase
Phase 2
People taking part
150 people, planned
Started
10 Jan 2022
Expected to end
30 Dec 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Testosterone Undecanoate 250 MG/ML
  • Placebo
Record updated
27 July 2026

Who can take part

Age
18 years and older
Sex
Men only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • History of prostate cancer or breast cancer
  • Known history of organic hypogonadism (e.g., due to hypothalamic, pituitary or testicular disease)
  • Uncontrolled congestive heart failure
  • Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within 3 months
  • Diagnosis of bipolar disorder or schizophrenia
  • Serum creatinine >2.5 mg/dL
  • Alanine aminotransferase (ALT) level 3 times above the upper limit of normal
  • 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

Where in United States

  • Brigham and Women's HospitalBoston, United StatesContact: Julia CrosbyTaking people

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • TestosteroneTreatment being tested

    Intramuscular injections of testosterone undecanoate 750 mg.

    Treatment: Testosterone Undecanoate 250 MG/ML

  • PlaceboPlacebo, for comparison

    Intramuscular injections of placebo.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Androgen Replacement to Improve Patient-Important Outcomes in Men With Opioid-Induced Hypogonadism
Record updated
27 July 2026