A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Cyclic Oral Administration of FSN-013 (E4/DRSP) in Japanese Patients With Endometriosis

Fuji Pharma Co., Ltd.0 个研究点目标入组 150 人开始时间: 2021年8月2日最近更新: 2023年10月31日

适应症

试验速览

暂无简介。

•1.Diagnosed as endometriosis by laparotomy or laparoscopy
•2.Diagnosed as endometriosis (having ovarian chocolate cysts) by TVUS or MRI
•3.Patients clinically diagnosed as endometriosis with any of Douglas fossa induration or limited uterine mobility or pelvic tenderness by vaginal or rectal examination
•4.Aged >= 20 years at the time of informed consent
•5.BMI < 30 kg/m2

•1.Unconfirmed diagnosis of abnormal vaginal bleeding within 6 months before the screening tests
•2.Aged >= 40 years with ovarian chocolate cysts for which the largest diameter was > 10 cm
•3.Ovarian chocolate cysts containing solid components
•4.Had undergone surgical treatment for endometriosis, adenomyosis and uterine fibroids by cyst puncture (such as transvaginal alcohol fixation), laparotomy or laparoscopy within 2 months before screening

The amount of change in the most severe pelvic pain (lower abdominal pain / back pain)

未报告次要终点

发起方