Recruiting
Phase 2

Testosterone

Sponsor:

Brigham and Women's Hospital

Code:

NCT04798469

Conditions

Opioid Use

Pain

Hypogonadism, Male

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Testosterone Undecanoate 250 MG/ML

Placebo

Study Details

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 with placebo in men with chronic spinal pain treated with opioids who have opioid-induced hypogonadism (low testosterone).

Conditions

Opioid Use

Pain

Hypogonadism, Male

Study ID

NCT04798469

Start date

Jan 10, 2022

Status verified date

Jul, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Testosterone

Intramuscular injections of testosterone undecanoate 750 mg.

placebo comparator: Placebo

Intramuscular injections of placebo.

Interventions

Testosterone Undecanoate 250 MG/ML

Intramuscular administration at a dose of 750 mg at baseline, weeks 4, and week 14.

Placebo

Intramuscular administration of placebo at baseline, weeks 4, and week 14.

Primary outcome measure

  • Changes in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire [ Time Frame: Baseline, 3 months, and 6 months ]

Central Contacts and Locations

Central contacts

Julia Crosby

617-525-6726jpcrosby@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Julia Crosby

617-525-6726jpcrosby@bwh.harvard.edu

Principal Investigator:

Shehzad Basaria, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • Pain
  • Opioid Analgesics
  • Testosterone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-07-27.