Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Assess the Efficacy and Safety of GenSci048 in Patients With Moderate to Severe Endometriosis-Associated Pain
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2025-08-12
200
Participants Needed
1
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Phase IIa Clinical Study to Assess the Efficacy and Safety of GenSci048 in Patients With Moderate to Severe Endometriosis-Associated Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants between 18 and 49 years old at the time of consent
- Diagnosed with endometriosis within 10 years before screening
- Experiencing moderate to severe pain related to endometriosis
- Having at least one regular natural menstrual cycle lasting 21 to 35 days before and during screening
- Agreeing to switch to only permitted analgesic medications during the study and stop other endometriosis treatments
- Agreeing to use non-hormonal contraception from consent until 4 weeks after the last study dose
You will not qualify if you...
- Previous hysterectomy or bilateral oophorectomy, or planning these surgeries during the study
- Chronic pelvic or non-pelvic pain unrelated to endometriosis requiring ongoing treatment affecting pain assessment
- Pelvic ultrasound showing need for surgery or suspicion of cancer
- Abnormal or unexplained vaginal or uterine bleeding within 3 months before screening
- Planned elective surgery during the study or recent surgery within 4 months requiring pain management
- History of severe depression, post-traumatic stress disorder within 2 years, or other severe mental disorders
- History of drug or alcohol abuse in the 6 months before screening
- Participation in any other interventional clinical trial within 1 month before screening
- Use of prohibited anesthetics for more than 2 weeks in the 6 months before screening
- Pregnancy, breastfeeding, or planning pregnancy
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive GenSci048 or placebo administered subcutaneously every 4 weeks to assess the efficacy and safety in reducing endometriosis-associated pain.
Monthly visits for injections and assessments
Duration - Up to approximately 4 weeks after last dose
Participants are monitored for safety and long-term effects after completing treatment.
1 to 2 visits for safety monitoring
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
J
Jingsi Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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