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 Dysmenorrhea

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.Secondary dysmenorrhea
•Diagnosed as Endometriosis or Adenomyosis by laparotomy or laparoscopy
•Diagnosed as Endometriosis with ovarian chocolate cysts or Adenomyosis or Uterine fibroids by TVUS or MRI
•2.Functional dysmenorrhea
•Patients whose secondary dysmenorrhea was ruled out by history taking, vaginal examination, and TVUS, etc.
•3.Aged >= 20 years at the time of informed consent
•4.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 total dysmenorrhea score

未报告次要终点

发起方