GenSci048 for moderate to severe endometriosis pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase IIa, placebo-controlled interventional trial gives premenopausal women with moderate to severe endometriosis-associated pain either GenSci048 or a matching placebo to compare pain relief and safety. Eligible participants are aged 18–49, have a diagnosis of endometriosis within the past 10 years, regular natural menstrual cycles, and must agree to use only permitted analgesics and non-hormonal contraception during the study. The trial will track changes in pain and record adverse events to determine whether GenSci048 provides meaningful symptom improvement. Specific dosing schedules and treatment duration are set by the sponsor and monitored throughout the study.

Why it matters

Who can join: the full rules

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/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.

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Jingsi Li
• Email: lijingsi@genscigroup.com
• Phone: +86 18301941524

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating physical therapy for endometriosis pain management

  This study is testing if a mix of education about pain and specific exercises can help women with endometriosis feel less pain and improve their quality of life.

  Recruiting University of Seville · Seville · NCT06795243

• Hyperbaric Oxygen Therapy for Pain from Endometriosis

  This study is testing if Hyperbaric Oxygen Therapy can help women with endometriosis who have been in pain for a long time feel better while they wait for surgery.

  Recruiting Sunnybrook Health Sciences Centre · Toronto, Ontario · NCT06579040

• Comparing different techniques to treat endometriosis

  This study is testing different methods to treat endometriosis, like laser and heat techniques, to see which one works best for relieving pain in women who are already having surgery for the condition.

  Recruiting TriHealth Inc. · Cincinnati, Ohio · NCT06414083

• Exploring the connection between the jaw joint and pelvis in women with certain health issues

  This study is testing if a special therapy can help women with prolapse and endometriosis-related pain by looking at how the jaw joint and pelvis are connected.

  Recruiting Poznan University of Physical Education · Poznan · NCT05978414

• Using a smartphone app to track pain and mood changes

  This study is testing a smartphone app to track pain and mood changes in people with chronic pain and healthy individuals to see how these factors affect pain over time.

  Recruiting Brown University · Providence, Rhode Island · NCT05754190

• Using electrical stimulation to relieve chronic pain from endometriosis

  This study is testing whether using electrical stimulation can help relieve chronic pain in people with endometriosis better than regular pain medications.

  Recruiting Göteborg University · Gothenburg · NCT05152264

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.