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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

About this study

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.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Placebo
  • 2.Take Testosterone Undecanoate 250 MG/ML
PhasePhase 2
DrugTestosterone Undecanoate 250 MG
Routeinjection
Primary goalChanges in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low8%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

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