Status:
RECRUITING
Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Opioid Use
Pain
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 wit...
Detailed 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 placeb...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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%.
- Prostate-specific antigen (PSA) level \>4 ng/mL in Caucasians or \>3 ng/mL in African-Americans.
- Presence of prostate nodule or induration on digital rectal examination.
- Uncontrolled congestive heart failure.
- Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within 3 months.
- Serum creatinine \>2.5 mg/dL.
- Alanine aminotransferase (ALT) level 3 times above the upper limit of normal.
- Diagnosis of bipolar disorder or schizophrenia.
- Presence of metallic implants (pacemakers, aneurysm clips, etc.) that preclude the patient from undergoing functional magnetic resonance imaging (MRI). In subjects who are otherwise eligible and either do not qualify for MRI or are reluctant to undergo imaging, the investigators may consider enrolling such participants on a case-by-case basis.
Key Trial Info
Start Date :
January 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04798469
Start Date
January 10 2022
End Date
June 30 2026
Last Update
June 19 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115