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:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT04150406
Eligibility Criteria:
Inclusion Criteria:
* Premenopausal women between the ages of 18 and 51 years
* Ability to comprehend the full nature and purpose of the study
* Signed informed consent
* Diagnosed endometriosis (peritoneal, ovarian or deep-infiltrating endometriosis (DIE))
* By laparoscopy or laparotomy with histological verification diagnosed up to 10 years before screening
* By ultrasound or MRI (ovarian or deep-infiltrating endometriosis, as peritoneal lesions can only be evaluated surgically)
* Moderate to severe pelvic pain (i.e. dysmenorrhea or NMPP of at least 4 on the 1-10 NRS) at least during the past 3 months
* Refusal of hormonal treatments
* The patient must agree to switch from her usual analgesic rescue medication to only the one permitted by the study during screening, treatment and follow-up period
Exclusion Criteria:
* The patient is pregnant or breast feeding or is planning a pregnancy within the treatment period
* Known addiction (alcohol, drugs, pills, etc...)
* Liver or kidney problems
* Known problems of the bile system
* Infection (HIV, Hepatitis, TBC, etc..) or systemic autoimmune diseases
* Known or suspected malignant disease
* Intake of blood-thinning medication (such as heparin or aspirin for example)
* Intake of hormonal contraceptives (oral during the last 4 weeks, injectable: during the last 3 months)
* Patient with a surgical history of hysterectomy, bilateral adnexectomy, endometrial ablation resulting in amenorrhea
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
51 Years
Study:
NCT04150406
Study Brief:
Protocol Section:
NCT04150406