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Study details
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Pain Relief With Testosterone for Men on Opioids

Brigham and Women's Hospital
NCT IDNCT04798469ClinicalTrials.gov data as of Apr 2026
Phase

Phase 2

Target enrollment

150

Study length

about 4.5 years

Ages

18+

Sex

Male only

Locations

1 site in MA

What this study is about

Researchers are testing whether testosterone treatment improves pain, sexual function, fatigue, and quality of life in men with chronic pain who are also taking opioids. The trial will compare testosterone to a placebo.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Placebo
  • 2.Take Testosterone Undecanoate 250 MG/ML

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Injection / IVintramuscular

How treatment is administered

Treatment Assignment
Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers) (Androgen Receptor Agonists)

Drug routes

injection, intramuscular

Endpoints

Primary: Changes in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire

Secondary: Changes in response to quantitative sensory testing of pain under a mechanical stimulus, Changes in response to quantitative sensory testing of pain under cold stimulus, Changes in response to quantitative sensory testing of pain under deep pressure stimulus, Changes in response to quantitative sensory testing of pain under heat stimulus, Changes in response to quantitative sensory testing of pain under pressure stimulus

Body systems

Psychiatry / Mental Health