Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism
Recruiting
Phase 2
Interventional Study
Opioid Use
Pain
Hypogonadism, Male
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Brigham and Women's Hospital · Other
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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).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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.
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Contacts