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.
Parallel
GenSci048
DrugAdministered SC.
Placebo
DrugAdministered SC.
Change of dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS)
The NRS for overall endometriosis-associated pain ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Change of non-menstrual pelvic pain (NMPP) measured by Numeric Rating Scale (NRS)
The NRS for overall endometriosis-associated pain ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Change of DYS, NMPP, and dyspareunia (DYSP) measured by Numeric Rating Scale (NRS). The NRS for overall endometriosis-associated pain ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Permitted rescue medication use.
Patient Global Impression of Change, Patient Global Impression of Change (minimum 1, maximum 7, higher score mean a worse outcome).
Adverse Event
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