Androgen Replacement to Improve Patient-Important Outcomes in Men With Opioid-Induced Hypogonadism
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Changes in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Testosterone
Intramuscular injections of testosterone undecanoate 750 mg.
干预措施: Testosterone Undecanoate 250 MG/ML (Drug)
Placebo
Intramuscular injections of placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire
时间窗: 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.
次要结局
- 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)
研究者
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