The Effect of Testosterone Replacement in Patients With Hypogonadotrophic Hypogonadism Due to Opioid Treatment for Non-malignant Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- lean body mass
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of testosterone replacement therapy in men with low testosterone due to opioid treatment on body composition, the haemostatic system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids, sexual function and quality of life.
Male patients on opioids for non-malignant diseases aged 18-59 years diagnosed with hypogonadotrophic hypogonadism, referred from day hospitals and outpatient populations. 40 patients are randomized to either testosterone undecanoate i.m. or placebo i.m., i.e. 20 patients per arm
A double blinded randomized placebo controlled trial
详细描述
The study duration is 24 weeks. Patients are treated with Testosterone Undecanoate 1000 mg/4 ml, intramuscular (i.m.) or placebo at 0, 6 and 18 weeks.
Outcome measures will be evaluated at 0 and 14 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients 18-75 years
- •Treatment with opioid for >3 months, daily dose >50-100 mg
- •Total testosterone < 12 mmol/L
- •Follicle Stimulating Hormone (FSH)/Luteinizing Hormone (LH) levels normal og below normal laboratory values
- •Normal prolactin levels
排除标准
- •Hematocrit> 54% at screening
- •Prostate Specific Antigen (PSA) > 3 ng/ml
- •Severe organic and mental disease
- •current or present cancer diagnosis
- •Previous venous thrombotic embolism and cerebrovascular disease
- •Uncontrolled hypertension
- •Epilepsy or migraine not adequately controlled by therapy
- •Severe benign prostate hypertrophy with symptom score >19
- •Sleep apnea
- •Alcohol or drug abuse
- •Implantation of sustained action sex hormone in the last 12 months
- •Use of oral, buccal or transdermal testosterone in the last two weeks
- •Treatment with glucocorticoids > 5 mg/day or 5 alfa reductase inhibitors
- •Hypersensitivity to Nebido
研究组 & 干预措施
placebo
intramuscular injection
干预措施: placebo (Drug)
testosterone
intramuscular injection
干预措施: Testosterone (Drug)
结局指标
主要结局
lean body mass
时间窗: 24 weeks
dual xray absorptiometry scan
次要结局
未报告次要终点
研究者
Marianne Andersen
Professor, MD,
Odense University Hospital