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:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT03991520
Eligibility Criteria:
Inclusion Criteria:
* Women aged 18-45 with regular menstrual periods every 24-32 days and not lasting more than 10 days per month
* Surgical or imaging proven endometriosis.
* At least a moderate level of menstrual pain based on the patient reported parameters of the B\&B pain scale (\>4/9) with dysmenorrhea being scored at least 2/3.
* Willing to remain on your current method of hormone therapy for duration of study
Exclusion Criteria:
* History of hysterectomy or oophorectomy.
* Non-response to GnRH agonist/antagonist, DMPA, aromatase inhibitors or danazol.
* Currently pregnant or attempting pregnancy.
* Contraindication to anakinra.
* Chronic kidney disease stage 4 and 5 or creatinine clearance \<30mL/min/1.73m2.
* Abnormal LFTs, CBC or serum electrolytes including estimated GFR.
* Patient refusal.
* Plan to receive a live vaccine
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03991520
Study Brief:
Protocol Section:
NCT03991520