This study is designed to evaluate the safety and efficacy of GenSci048 for moderate to severe endometriosis-associated pain treatment.
Pre-menopausal female participants, between 18 and 49 years of age, inclusive, at the time of signing informed consent.
Participants must have a diagnosis of endometriosis within 10 years before screening.
Have moderate to severe endometrial related pain.
Have at least one regular, natural menstrual cycles (ranging from 21 to 35 days (inclusive)) before and during the screening period.
Participants who have previously received hysterectomy and/or bilateral oophorectomy, or plan to undergo these procedures during the study period.
Participants who suffer from chronic pelvic and/or non-pelvic pain that is not caused by EM and require chronic analgesia or other chronic treatment, which is expected to affect the assessment of EAP.
Pelvic ultrasound screening indicating a need for surgery or suspicion of malignancy.
Participants with abnormal and undiagnosed vaginal and/or uterine bleeding within 3 months prior to screening.
Changchun GeneScience Pharmaceutical Co., Ltd.
Lead sponsor