Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorBrigham and Women's Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
History of prostate cancer or breast cancer.
Known history of organic hypogonadism (e.g., due to hypothalamic, pituitary or testicular disease).
Use of testosterone within the past 6 months.
Baseline hematocrit >48%.
Trial design
Treatments tested in this trial
- Testosterone Undecanoate 250 MG/ML
- Placebo
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov