EUCTR2008-001687-37-HU进行中（未招募）不适用
An open label, parallel group phase III clinical study in patients with prostate cancer to demonstrate the non-inferiority of a new Novosis Leuprorelin 10.72 mg implant versus the reference product Trenantone
ovosis AG0 个研究点开始时间: 2008年5月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- 性别
- Male
入选标准
- •Males aged 18 years or older
- •Histologically confirmed diagnosis of carcinoma of the prostate suitable for hormonal manipulation including patients with rising PSA after having undergone surgery or radiotherapy with curative intention
- •Life expectancy of at least six months
- •The patient is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the Consent Form
- •The patient is able to understand and follow instructions and is able to participate in the study for the entire period
- •Patients must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Hypersensitivity to Trenantone® or to other GnRH analogues
- •Treatment with a drug modifying testosterone level or function is prohibited. To these belong e.g. flutamide, spironolactone, domperidone, cimetidine, amitriptyline, methyldopa, minoxidil, and finasteride
- •Treatment and/or pretreatment with other GnRH analogues
- •Patients considered being candidates for curative therapy i.e. radical prostatectomy or radiotherapy within 6 months from inclusion
- •Cancer disease within the last 10 years except prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin
- •Patients with clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or any infectious disorder or any other condition including alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study as judged by the investigator
- •Mental incapacity or language barriers precluding adequate understanding or co-operation
- •Patients who have received an investigational drug within the last 12 weeks preceding Visit 1
- •Previous participation in this study
研究者
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