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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 25
- 试验地点
- 15
- 主要终点
- Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l).
研究概览
简要总结
The active ingredient of Pamorelin® 11,25 mg is Triptorelin. Triptorelin is a substitute for a natural hormone produced in the body called Gonadotrophin-releasing hormone (GnRH). GnRH is a hormone secreted by hypothalamus (a gland located in brain) and controls the production of sex hormones (eg testosterone in men) in other organs in the body. The growth of prostate cancer cells, one of the most common cancers in men, is induced by the hormone testosterone. Hormonotherapy is one of treatments available to treat this type of disease by controlling the testosterone serum level. Pamorelin® 11,25 mg is normally injected in the muscle but this type of injection is not suitable for every patient. Therefore the primary purpose of this study is to assess the non-inferiority of the 12-week triptorelin formulation Pamorelin® 11,25 mg administered via subcutaneous (SC) injection as compared to Pamorelin® 11,25 mg administered via standard intramuscular (IM) injection based on the percentage of patients presenting a testosterone level ≤ 50 ng/dl at week 24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histological proven prostate cancer, locally advanced or metastatic and scheduled to receive hormonal deprivation therapy
- •Life expectancy of more than 9 months
- •Documented testosterone levels of ≥ 125 ng/dl measured by any laboratory or on site within the previous 6 months
排除标准
- •Has a history of hypersensitivity to the Investigational Medicinal Product or drugs with a similar chemical structure
- •Has previously received a GnRH analogue, estrogens or a steroidal anti -androgen within the last year preceding the study
- •Concomitant anti-coagulation treatment
- •Patient who underwent an orchidectomy or who is scheduled to receive an orchidectomy during the course of this study
- •Patient with known spinal medullar compression
研究组 & 干预措施
1
triptorelin 11.25mg given 12 weekly by subcutaneous formulation
干预措施: Triptorelin (Decapeptyl®) (Drug)
2
triptorelin 11.25mg given 12 weekly by intramuscular injection
干预措施: Triptorelin (Decapeptyl®) (Drug)
结局指标
主要结局
Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l).
时间窗: Week 24
次要结局
- Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l).(Measured at week 12)
- Patient acceptability of the injection; the pain experienced during injection, scored by means of a Visual Analogue Scale (VAS).(Measured at baseline and 12 weeks)
- Care giver acceptability of the administration of the injection by means of a Visual Analogue Scale (VAS).(Measured at baseline and 12 weeks)