A Phase IIa Clinical Study to Assess the Efficacy and Safety of GenSci048 in Patients With Moderate to Severe Endometriosis-Associated Pain
Trial Parameters
Brief Summary
This study is designed to evaluate the safety and efficacy of GenSci048 for moderate to severe endometriosis-associated pain treatment.
Eligibility Criteria
Inclusion Criteria: 1. Pre-menopausal female participants, between 18 and 49 years of age, inclusive, at the time of signing informed consent. 2. Participants must have a diagnosis of endometriosis within 10 years before screening. 3. Have moderate to severe endometrial related pain. 4. Have at least one regular, natural menstrual cycles (ranging from 21 to 35 days (inclusive)) before and during the screening period. 5. Agree to switch from her usual analgesic medication to only that which is permitted in the study from the screening period to the end of treatment and agree to stop using other treatments for endometriosis. 6. Agree to use non-hormonal contraception from the time of signing the informed consent until 4 weeks after the last dose of the study medication. Exclusion Criteria: 1. Participants who have previously received hysterectomy and/or bilateral oophorectomy, or plan to undergo these procedures during the study period. 2. Participants who suffer from chronic pelvic and/