EUCTR2014-004729-42-DK进行中（未招募）1 期
The effect of testosterone replacement in patients with hypogonadotroph hypogonadism due to opioid treatment for non-malignant disease A double-blinded, randomized and placebo-controlled trial - NA
Odense University Hospital, department M0 个研究点目标入组 40 人开始时间: 2015年2月13日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Male patients aged 18-59 years
- •Treatment with opioid for >3 month, daily dose > 50-100 mg (for conversion see Annex 1)
- •Total testosterone < 10 nmol/l
- •FSH/LH levels normal or below normal laboratory values.
- •Normal Prolactin levels
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Hematocrit > 54 % at screening
- •PSA > 3 ng/ml.
- •Routine blood sample values above range (TSH, ionized calcium, hemoglobin, liver- and kidney function tests)
- •Severe organic or mental disease reasonably suspected from history and/or clinical examination
- •Past or present breast or prostate cancer
- •Past or present liver tumors or acute or chronic hepatic diseases
- •Any current diagnosis of cancers
- •Acute thrombotic or embolic diseases
- •Previous VTE and Cerebrovascular disease
- •Uncontrolled hypertension (SBP>160mmHg and/or DBP>100mmHg) despite adequate antihypertensive therapy
- •Chronic debilitating disease (kidney failure, cirrhosis, HIV, COPD, heart failure or ischemic heart disease).
- •Epilepsy or migraine not adequately controlled by therapy.
- •Severe benign prostatic hypertrophy with IPSS symptom score above 19 (annex 2)
- •Sleep apnea
- •Any indication of drugs and/or alcohol abuse (>50 g alcohol a day)
- •Implantation of a sustained-action sex hormone in the last 12 months
- •Use of oral, buccal or transdermal testosterone therapy in the last 2 weeks before the first study medication, or intramuscular testosterone ester other than TU in the last 6 week, or TU injection in the last 6 months or use of androgens during the entire study period (except the study medication)
- •Blood coagulation irregularities presenting an increased risk of bleeding after intramuscular injection
- •Treatment with glucocorticoids >5mg/day and 5 alfa reductase inhibitors.
- •Hypersensitivity to Nebido
- •BMI>40 kg/m2
研究者
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