Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism
RecruitingPhase 2
Androgen Replacement to Improve Patient-Important Outcomes in Men With Opioid-Induced Hypogonadism
Who can join
Ages 18 and older · Men
Full 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. Exclusion Criteria: * 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.
About the study
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).
What is being tested
- Testosterone Undecanoate 250 MG/ML (drug)
- Placebo (drug)
Sponsor: Brigham and Women's Hospital · Participants: 150 · Started: Jan 10, 2022
Contact the study team
- Julia Crosby · Phone: 617-525-6726
Official record on ClinicalTrials.gov — NCT04798469
Locations in the U.S.
| Massachusetts | Brigham and Women's Hospital, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.