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Pilot Study of the IL-1 Antagonist Anakinra for the Treatment of Endometriosis Related Symptoms
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.
Details
| Lead sponsor | University of California, San Diego |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | UNKNOWN |
| Enrolment | 20 |
| Start date | 2020-06-16 |
| Completion | 2022-01 |
Conditions
- Endometriosis
- Anakinra
- Markers of Inflammation
Interventions
- Anakinra 100Mg/0.67Ml Inj Syringe
- Placebo
Primary outcomes
- Comparison of the impact of anakinra versus placebo on menstrual pain (dysmenorrhea) using the modified Biberoglu and Behrman scale. — Subjects will complete the baseline questionnaire at Visit 1. Subjects will fill out monthly questionnaires after the administration of either anakinra or placebo during 6 menstrual periods.
The primary pain outcome measure is to determine the impact of anakinra on dysmenorrhea due to endometriosis, using the modified Biberoglu and Behrman scale. The modified Biberoglu and Behrman scale consists of three patient-reported symptoms (dysmenorrhea, dyspareunia, and non-menstrual pelvic pain). Each of these is separately graded on a scale from 0 to 3, with a max of 9 and higher numbers indicating more severe symptoms. Changes in dysmenorrhea is the primary endpoint.
Countries
United States