Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Hypogonadism, Male
  • Opioid Use
  • Pain
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

This single-center, randomized, double-blind, placebo-controlled, parallel-group trial will evaluate pain and quality of life outcomes associated with 6 months of treatment with testosterone or placebo in men aged 18 years or older with chronic non-cancer back pain who are taking opioid analgesics f...

This single-center, randomized, double-blind, placebo-controlled, parallel-group trial will evaluate pain and quality of life outcomes associated with 6 months of treatment with testosterone or placebo in men aged 18 years or older with chronic non-cancer back pain who are taking opioid analgesics for at least 6 months and have opioid-induced hypogonadism.

Tracking Information

NCT #
NCT04798469
Collaborators
Not Provided
Investigators
Principal Investigator: Shehzad Basaria, MD Brigham and Women's Hospital Principal Investigator: Robert R Edwards, PhD Brigham and Women's Hospital