Pilot Study of the IL-1 Antagonist Anakinra for the Treatment of Endometriosis Related Symptoms
Status unconfirmed · Early Phase 1 · Has a placebo group
Conditions studied: Endometriosis, Anakinra, Markers of Inflammation
In brief
All current FDA approved medications to treat endometriosis pain including danazol, GnRH agonists (Lupron, Zoladex and Synarel), GnRH antagonist (elagolix) and depo-provera prevent or contradict pregnancy. Therefore women suffering from endometriosis and trying to conceive have no medical options apart from pain meds. The purpose of this pilot study is to determine whether the anti-inflammatory, IL-1 inhibitor (anakinra) reduces pelvic pain due to endometriosis without altering menstrual cycles, which is an indicator of ovulatory function. Anakinra is an FDA approved injectable medication for the treatment of rheumatoid arthritis that is pregnancy category B.
Key facts
- Study ID
- NCT03991520
- Run by
- University of California, San Diego
- People needed
- 20
- Starts
- 2020-06-16
- Expected to finish
- 2022-01-01
- Last updated by the study team
- 2021-05-28
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UCSD Reproductive Endocrinology — La Jolla, California, United States (enrolling)
Full record on ClinicalTrials.gov
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