NCT00244452已完成2 期
A Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy, Safety and Duration of Effect of a Single Administration of Various Doses of Cetrorelix SR in Subjects With Histologically Confirmed Endometriosis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 86
研究概览
简要总结
Identify effective doses of cetrorelix SR in the treatment of symptoms of endometriosis, describe dose effect relationship and duration of symptom relief
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
- Double
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal female,
- •history of regular menstrual periods,
- •any of the symptoms dysmenorrhea,
- •dyspareunia or pelvic pain assessed as moderate to severe,
- •endometriosis confirmed by histology within 36 months,
- •use of barrier contraception throughout the study
排除标准
- •Insufficient wash out period for other endometriosis treatments,
- •resection or destruction of endometriotic lesions less than 12 weeks prior to screening,
- •need for strong opioid analgesics,
- •need for immediate surgical treatment of endometriosis,
- •any condition that interferes with adherence to study procedures or study assessments
研究者
研究点 (86)
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