Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT05894135
Eligibility Criteria:
Key Inclusion Criteria:
1. The subject must be a premenopausal woman aged ≥18 years.
2. The subject must have had her most recent surgical and histological diagnosis of pelvic endometriosis (laparoscopy, laparotomy, vaginal fornix or other biopsy) within 10 years and at least 2 months ago prior to screening.
3. The subject has moderate to severe EAP during the screening period defined as:
1. At the screening visit, a score of at least 2 for DYS and at least 2 for NMPP for the previous month assessed with the modified Biberoglu \& Behrman (mB\&B) scale
2. Subject is confirmed to meet the following criteria during the screening period, within 35 consecutive calendar days prior to the baseline visit:
i. Mean overall pelvic pain scores on the 0-10 NRS over the 5 days with the highest score ≥ 4; ii. At least two days with "moderate" or "severe" pain on the 0-3 VRS for pelvic pain over the days with uterine bleeding; iii. At least two days with "moderate" or "severe" pain on the 0-3 VRS for pelvic pain over the days without uterine bleeding;
4. The subject has a Body Mass Index (BMI) ≥ 18 kg/m2 at the screening visit
Key Exclusion Criteria:
1. The subject is pregnant or breastfeeding, or plans to become pregnant during the study treatment period.
2. The subject has a surgical history of:
1. Hysterectomy,
2. Bilateral oophorectomy,
3. Surgeries that interfere with gastrointestinal motility, pH value, or absorption (including vagotomy, enterectomy, or gastric surgery),
4. Any major abdominal surgery (including laparotomy for endometriosis) within 6 months or any interventional surgery for endometriosis (i.e. laparoscopy) performed within a period of 2 months before screening, or the subject is scheduled for a surgical abdominal procedure during the course of the study.
3. The subject may need to take prohibited medications during the study or in the stipulated time before screening
4. The subject has a contra-indication to ABT
5. The subject has chronic pelvic pain that, in the opinion of the Investigator, is not caused by endometriosis and requires chronic analgesic or other chronic therapy which would interfere with the assessment of EAP
6. The subject has conditions that affect bone mass density (BMD) assessment
7. The subject did not respond to prior treatment with GnRH agonists or GnRH antagonists for endometriosis
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05894135
Study Brief:
Protocol Section:
NCT05894135