Frontlight ResearchEarly access
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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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