跳至主要内容
临床试验/NCT00938496
NCT00938496已完成不适用

A Non-interventional Study of Postoperative Treatment With Goserelin Acetate (Zoladex) in Moderate to Severe Endometriosis Patient

AstraZeneca1 个研究点 分布在 1 个国家目标入组 408 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
408
试验地点
1
主要终点
Symptom recurrence rate and total recurrence rate

研究概览

简要总结

This is a prospective, open label NIS, which is to assess the efficacy of Zoladex in adjuvant setting after operation in moderate to severe endometriosis patients.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Advanced endometriosis confirmed histologically (r-AFS score III-IV) with conservative laparoscopy or laparotomy.
  • Patient who has the indication of Zoladex and has been prescribed Zoladex according to physician's judgement, irrespective of the inclusion in the study.
  • Patient has been already prescribed Zoladex within 1 month after operation.

排除标准

  • Have used hormone treatment prior to 3 months of recruitment.
  • Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site).
  • Previous enrolment in the present study.

结局指标

主要结局

Symptom recurrence rate and total recurrence rate

时间窗: 18 months

次要结局

  • Pregnancy rate(18 months)
  • Zoladex administration time(6 months)
  • Add-back therapy information(18 months)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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