Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT04798469
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Testosterone Undecanoate 250 MG/ML — DRUG
    Intramuscular administration at a dose of 750 mg at baseline, weeks 4, and week 14.
  • Placebo — DRUG
    Intramuscular administration of placebo at baseline, weeks 4, and week 14.

Study Details

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).

Key Dates

First listed
Mar 15, 2021
Start date
Jan 10, 2022
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Testosterone
    Intramuscular injections of testosterone undecanoate 750 mg.
  • Placebo Comparator: Placebo
    Intramuscular injections of placebo.

Primary Outcome Measure

Changes in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire [ Time Frame: Baseline, 3 months, and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Julia Crosby
[email protected]
617-525-6726
Shehzad Basaria, MD (PRINCIPAL_INVESTIGATOR)
Robert R Edwards, PhD (PRINCIPAL_INVESTIGATOR)
Vitaly Napadow, PhD (SUB_INVESTIGATOR)
Thomas G Travison, PhD (SUB_INVESTIGATOR)

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