Treatment With Long Acting GnRH Antagonist Degarelix in Women With Endometriosis Recurrence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 3
- 主要终点
- disease free time
研究概览
简要总结
The long acting GnRH antagonist degarelix will be tested for the treatment of women with endometriosis recurrence compared with classical GnRH analog treatment. Pain symptom disappearance and disease free time during follow-up will be the outcomes for establishing which medical treatment is the best in endometriosis recurrence treatment.
详细描述
Endometriosis is a chronic disease affecting 5-10% of women in reproductive age, showing recurrence after surgery at least in 20-50% after 5 years of follow-up. The long acting GnRH antagonist degarelix, which do not have the flare-up effect at the opposite of GnRH agonist and strongly suppress LH secretion and thecal cell activity may show a better effects on endometrial implants than GnRH agonist.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women affected by endometriosis showing recurrence of pain symptoms
- •previous surgery for endometriosis
排除标准
- •presence of other systemic diseases
研究组 & 干预措施
Degarelix
180 women will be treated with degarelix 120mg in one administration
干预措施: degarelix (Drug)
leuprolide acetate 11.25 mg/ml
180 women will be treated with leuprolide acetate 11.25 mg/ml only once covering three months
干预措施: Leuprolide Acetate 11.25 MG/ML (Enantone 11,25) (Drug)
结局指标
主要结局
disease free time
时间窗: 24 months
time without pain symptoms due to the disease recurrence
次要结局
- time of disappearance pain(24 months)