Exploring the Role of Testosterone as a Novel Anti-Nociceptive Agent in Women With Chronic Pain and Opioid Use
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pain Interference Subscale score 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, physical function and quality of life when compared with placebo in women with chronic back pain treated with opioids who have 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 3 months of treatment with testosterone or placebo in women aged 60 years or older with chronic non-cancer back pain who are taking opioid analgesics for at least 6 months and have low testosterone.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women, age 60 years and older.
- •Chronic non-cancer back pain.
- •Use of opioid analgesics for at least 6 months.
- •Serum total testosterone <8.7 ng/dL and/or free testosterone <0.47 pg/mL.
- •Normal mammogram within the last 12 months
- •Endometrial thickness of <4 mm in women with an intact uterus assessed by endometrial ultrasound.
- •Ability and willingness to provide informed consent.
排除标准
- •History of breast or endometrial cancer
- •Estrogen therapy in the past 3 months
- •Baseline hematocrit >48%.
- •Serum creatinine >2.5 mg/dL.
- •HbA1c >9.0%. Subjects on insulin therapy will be excluded.
- •BMI >40 kg/m
- •Uncontrolled congestive heart failure.
- •Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within the past 3 months.
- •History of genetic thromboembolic disorder.
- •Diagnosis of bipolar disorder or schizophrenia.
- •Use of testosterone, spironolactone, finasteride or systemic ketoconazole in the past 3 months.
研究组 & 干预措施
Testosterone
Weekly intramuscular administration at a dose of 3 mg
干预措施: Testosterone Cypionate (Drug)
Placebo
Weekly intramuscular administration of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Interference Subscale score of the Brief Pain Inventory (BPI) questionnaire
时间窗: 3 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
- Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36)(3 months)
- Mood and well-being, assessed using the by Positive and Negative Affect Scale (PANAS) affectivity balance scale(3 months)
- Weighted Pinprick Stimulator-induced Mechanical Pain(3 months)
- Algometer-induced Pressure Pain(3 months)
- Ice Water-induced Cold Pain and Its After-sensation(3 months)
- Sexual Function assessed by the Female Sexual Distress Scale (FSDS)(3 months)
- Physical function, assessed using the 6-minute walk test (6-MWT)(3 months)
研究者
Shehzad Basaria, M.D.
Professor of Medicine
Brigham and Women's Hospital