An open label, parallel group, multiple dose Phase III clinical study in patients with prostate cancer to demonstrate the non-inferiority of a new Novosis Leuprorelin 3.57 mg implant versus the reference product Enantone? Monats-Depot

ovosis AG0 个研究点目标入组 40 人开始时间: 2008年3月13日最近更新: 2012年8月21日

适应症

试验速览

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•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

•Hypersensitivity to Enantone® 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
•Simultaneous or less than 30 days earlier participation in another clinical trial
•Known allergy against one of the ingredients in the test and reference preparation.

发起方

ovosis AG