jRCT2080225090已完成2 期
An open label, parallel group study to explore pharmacodynamics, pharmacokinetics and safety during 3 cyclic treatments of FSN-013 (E4/DRSP) in Japanese endometriosis patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multi-center, Open-label, Randomized, Parallel Group
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 49age old under（—）
- 性别
- Female
入选标准
- •Japanese patients, diagnosed as endometriosis by laparotomy/laparoscopy, and/or as having ovarian chocolate cysts by TVUS or MRI
- •Aged >= 20 and < 50 years
- •3.BMI < 30 kg/m2
排除标准
- •Undiagnosed abnormal vaginal bleeding 6 months before the screening tests
- •Aged >= 40 years with ovarian chocolate cyst for which the largest diameter was > 10 cm
- •Ovarian chocolate cyst containing solid components
- •Had undergone surgical treatment for endometriosis by cyst puncture (such as transvaginal alcohol fixation), laparotomy, or laparoscopy (laparoscopy) within 2 months prior to the screening tests
结局指标
主要结局
-
pharmacodynamics Severest pelvic pain (VAS)
次要结局
未报告次要终点
研究者
研究点 (1)
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