PHASE II MULTI-CENTRIC, RANDOMISED, OPEN-LABEL, PARALLEL-GROUP STUDY TO ASSESS THE NON-INFERIORITY OF PAMORELIN® 11,25MG SC INJECTED VERSUS PAMORELIN® 11,25MG IM INJECTED IN PATIENTS SUFFERING FROM ADVANCED PROSTATE CANCER - PAMOJECT

IPSEN FARMACEUTICA BV0 个研究点目标入组 210 人开始时间: 2006年7月21日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1) Provision of written informed consent prior to any study related procedures.
•2) Male patients aged 18 years and older
•3) Histological proven prostate cancer, locally advanced or metastatic and scheduled to receive hormonal deprivation therapy.
•4) Life expectancy of more than 9 months
•5) Documented testosterone levels of = 125 ng/dl measured by any laboratory or on site within the previous 6 months
•6) Patient able and willing to comply with the requirements of the protocol.
•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

•1) Has a history of hypersensitivity to the studied drug or drugs with a similar chemical structure.
•2) Was treated with any other Investigational Medicinal Product within the last 30 days before study entry.
•3) Has previously received a GnRH analogue, estrogens or a steroidal anti –androgen within the last year preceding the study.
•4) Concomitant anti-coagulation treatment.
•5) Patient who underwent an orchidectomy or who is scheduled to receive an orchidectomy during the course of this study.
•6) Patient with known spinal medullar compression.
•7) Has a history of, or known current, problems with alcohol abuse.
•8) Has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
•9) Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.

发起方

IPSEN FARMACEUTICA BV