Phase IIa Study to Evaluate the Safety and Effectiveness of GenSci048 Injection for Moderate to Severe Endometriosis Pain in Women Ages 18 to 49

What this Trial Is About

Researchers are evaluating GenSci048 for treating moderate to severe pain associated with endometriosis in pre-menopausal women. This randomized, double-blind, placebo-controlled Phase IIa study aims to assess the safety and effectiveness of GenSci048 in relieving endometriosis-related pain. The study is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. and focuses on women aged 18 to 49 who have been diagnosed with endometriosis within the past 10 years. Participants will receive either GenSci048 or a placebo by subcutaneous injection every four weeks. The treatment period includes regular dosing and monitoring over several months. Researchers will compare changes in pain levels, including menstrual pain and non-menstrual pelvic pain, using a numeric rating scale from baseline through week 24 and up to 52 weeks for secondary outcomes. During the study, participants will attend scheduled visits for assessments of pain, use of rescue medications, and overall health evaluations. Safety will be monitored through adverse event reporting for up to approximately 56 weeks. Pain changes will be measured with standardized scales, and participants will be asked about their impressions of change at multiple time points. Total participation may last over one year, including treatment and follow-up periods.

A Phase IIa Clinical Study to Assess the Efficacy and Safety of GenSci048 in Patients With Moderate to Severe Endometriosis-Associated Pain