Androgen Replacement to Improve Patient-Important Outcomes in Men With Opioid-Induced Hypogonadism
Overview
- Phase
- Phase 2
- Intervention
- Testosterone Undecanoate 250 MG/ML
- Conditions
- Opioid Use
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Changes in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire
- Status
- Recruiting
- Last Updated
- 18 days ago
Overview
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).
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 placebo in men aged 18 years or older with chronic non-cancer spinal pain who are taking opioid analgesics for at least 6 months and have opioid-induced hypogonadism.
Investigators
Shehzad Basaria, M.D.
Professor of Medicine, Harvard Medical School; Associate Director, Section on Men's Health, Aging & Metabolism, Brigham and Women's Hospital
Brigham and Women's Hospital
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.
Arms & Interventions
Testosterone
Intramuscular injections of testosterone undecanoate 750 mg.
Intervention: Testosterone Undecanoate 250 MG/ML
Placebo
Intramuscular injections of placebo.
Intervention: Placebo
Outcomes
Primary Outcomes
Changes in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire
Time Frame: Baseline, 3 months, and 6 months
The Pain Interference Subscale of the BPI is specifically relevant to patients with chronic back pain who are using opioids and correlates strongly with the patient's quality of life.
Secondary Outcomes
- Changes in response to quantitative sensory testing of pain under pressure stimulus(Baseline, 3 months, and 6 months)
- Changes in default mode network connectivity(Baseline and 6 months)
- Changes in response to quantitative sensory testing of pain under a mechanical stimulus(Baseline, 3 months, and 6 months)
- Changes in response to quantitative sensory testing of pain under heat stimulus(Baseline, 3 months, and 6 months)
- Changes in response to quantitative sensory testing of pain under deep pressure stimulus(Baseline, 3 months, and 6 months)
- Changes in response to quantitative sensory testing of pain under cold stimulus(Baseline, 3 months, and 6 months)