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Tests treatment safety and results for Endometriosis-related Pain
Official title A Phase IIa Clinical Study to Assess the Efficacy and Safety of GenSci048 in Patients With Moderate to Severe Endometriosis-Associated Pain
ClinicalTrials.gov ID: NCT06963177
What this study is testing
What is GenSci048?
GenSci048 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for endometriosis-related pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is designed to evaluate the safety and efficacy of GenSci048 for moderate to severe endometriosis-associated pain treatment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 49, women only
You may be able to join if
- Pre-menopausal female participants, between 18 and 49 years of age, inclusive, at the time of signing informed consent.
- Participants must have a diagnosis of endometriosis within 10 years before screening.
- Have moderate to severe endometrial related pain.
- Have at least one regular, natural menstrual cycles (ranging from 21 to 35 days (inclusive)) before and during the screening period.
- 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...
You likely can't join if
- Participants who have previously received hysterectomy and/or bilateral oophorectomy, or plan to undergo these procedures during the study period.
- 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...
- Pelvic ultrasound screening indicating a need for surgery or suspicion of malignancy.
- Participants with abnormal and undiagnosed vaginal and/or uterine bleeding within 3 months prior to screening.
- 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...
- History of severe depression or post-traumatic stress disorder within the two years prior to screening, or history of any other severe mental...
See the full eligibility criteria
- Pre-menopausal female participants, between 18 and 49 years of age, inclusive, at the time of signing informed consent.
- Participants must have a diagnosis of endometriosis within 10 years before screening.
- Have moderate to severe endometrial related pain.
- Have at least one regular, natural menstrual cycles (ranging from 21 to 35 days (inclusive)) before and during the screening period.
- 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.
- 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.
- Participants who have previously received hysterectomy and/or bilateral oophorectomy, or plan to undergo these procedures during the study period.
- 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.
- Pelvic ultrasound screening indicating a need for surgery or suspicion of malignancy.
- Participants with abnormal and undiagnosed vaginal and/or uterine bleeding within 3 months prior to screening.
- 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.
- 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.
- History of drug or alcohol abuse within the six months prior to screening.
- Participants who have participated in any other treatment clinical trial (including clinical trials of drugs and devices) within 1 month prior to screening.
- 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.
- Participant is pregnant, breast feeding, or planning a pregnancy.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 49 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.