Androgen Replacement to Improve Patient-Important Outcomes in Men With Opioid-Induced Hypogonadism
Who is this study for? Men with opioid-induced hypogonadism
What treatments are being studied? Testosterone Undecanoate
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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).
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Leila Chammas
lchammas@bwh.harvard.edu
617-278-0722
Time Frame
Start Date: 2022-01-10
Estimated Completion Date: 2025-04-30
Participants
Target number of participants: 150
Treatments
Experimental: Testosterone
Intramuscular injections of testosterone undecanoate 750 mg.
Placebo_comparator: Placebo
Intramuscular injections of placebo.
Authors
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital