A Phase IIa Clinical Study to Assess the Efficacy and Safety of GenSci048 in Patients With Moderate to Severe Endometriosis-Associated Pain
NCT ID: NCT06963177
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2025-05-26
2030-01-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of HS-10518 in Healthy Female Participants
NCT06118827
The Pharmacokinetic(PK)/Pharmacodynamics(PD) Study of SHR7280 Tablets in Premenopausal Subjects With Endometriosis.
NCT04417972
A Safety & Efficacy Study of BGS649 in Women With Refractory Endometriosis
NCT01116440
A Randomized, Placebo-controlled, Double-blind Study of KLH-2109 in Patients With Endometriosis (2)
NCT01533532
Safety and Efficacy Study of MT-2990 in Women With Endometriosis
NCT03840993
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GenSci048
GenSci048 subcutaneously (SC) every 4 weeks.
GenSci048
Administered SC.
Placebo
Administered SC every 4 weeks.
Placebo
Administered SC.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GenSci048
Administered SC.
Placebo
Administered SC.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
2. 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.
3. Pelvic ultrasound screening indicating a need for surgery or suspicion of malignancy.
4. Participants with abnormal and undiagnosed vaginal and/or uterine bleeding within 3 months prior to screening.
5. Participants who plan to schedule elective surgery during the study; or those who have had a surgery within 4 months prior to screening and need ongoing pain management.
6. History of severe depression or post-traumatic stress disorder within the two years prior to screening, or history of any other severe mental disorder at any time.
7. History of drug or alcohol abuse within the six months prior to screening.
8. Participants who have participated in any other interventional clinical trial (including clinical trials of drugs and devices) within 1 month prior to screening.
9. Have used a prohibited long-acting anesthetic or immediate-release anesthetic for more than 2 consecutive weeks for the treatment of endometriosis associated pain in the 6 months prior to screening.
10. Participant is pregnant, breast feeding, or planning a pregnancy.
18 Years
49 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking University First Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GenSci048-205
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.