JPRN-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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 49age old（—）
- 性别
- Female
入选标准
- •1. Japanese patients, diagnosed as endometriosis by laparotomy/laparoscopy, and/or as having ovarian chocolate cysts by TVUS or MRI
- •2. Aged >= 20 and < 50 years
- •3.BMI < 30 kg/m2
排除标准
- •1. Undiagnosed abnormal vaginal bleeding 6 months before the screening tests
- •2. Aged >= 40 years with ovarian chocolate cyst for which the largest diameter was > 10 cm
- •3. Ovarian chocolate cyst containing solid components
- •4. 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
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