NCT01014507已完成2 期
Randomisierte Phase II Studie Zum Einsatz Von Goserelin Und Oralen Kontrazeptiva Zur Reduktion Ovarieller Toxizitäten während Zytostatischer Primärtherapie Bei Fertilen Patientinnen Mit Hodgkin Lymphom in Fortgeschrittenen Stadien
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- FSH level 6 month after end of treatment
研究概览
简要总结
This study is designed to test the the protective capacity of Goserelin compared with oral contraceptive
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Advanced stage Hodgkins Lymphoma (histologically proven)
- •Normal FSH-levels
- •Written informed consent
排除标准
- •Hodgkins Lymphoma as "composite lymphoma"
- •Primary ovarial dysfunction
- •Age > 40
研究组 & 干预措施
A
Active Comparator
干预措施: 8 cycles BEACOPPesc plus oral contraceptive (Drug)
B
Experimental
干预措施: 8 cycles BEACOPPesc plus Goserelin (Drug)
结局指标
主要结局
FSH level 6 month after end of treatment
时间窗: 6 month
次要结局
未报告次要终点
研究者
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