Summary

for females ages 18-40 (full criteria)
at La Jolla, California
study started
estimated completion
Sanjay K Agarwal, MD

Description

Summary

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

Endometriosis is a chronic inflammatory disease1 that affects 5 -10% of reproductive aged women1,2. It is characterized by the presence of uterine endometrium outside the uterus. The condition causes health distress through pelvic pain and decreased QOL. Current therapies to temporarily control symptoms include surgery as well as medical options that prevent pregnancy and have significant side-effects.3,4 The most common symptoms with endometriosis include dysmenorrhea, dyspareunia and NMPP. Ultimately these lead to a decrease in QOL. All current medical therapies to treat endometriosis pain prevent or contradict pregnancy.

Inflammation is a well-established central figure in the pathophysiology of endometriosis(1). Increasingly, data is suggesting that IL-1 is a mediator of inflammation in endometriosis (2, 3). In addition, there are data that single nucleotide polymorphisms at the IL-1A gene locus are associated with endometriosis risk (4). Hence, it is rational to assess anakinra, an IL-1 antagonist, in the control of symptoms and inflammation due to endometriosis. Therefore, we propose this pilot study testing an FDA approved medication (anakinra) to reduce IL-1 and on dysmenorrhea due to endometriosis without stopping periods (a sign of ovulation).

Anakinra is a self-administered subcutaneous injectable medication that is FDA approved for the treatment of rheumatoid arthritis. As an IL-1 antagonist, it works by decreasing inflammation and is administered daily by the patient. Because Anakinra interferes with the immune system functioning, the major concern with the use of Anakinra is reduced resistance to infection. Others include injection site reactions such as redness, itching, rash, and pain. Bruising or bleeding also can occur, but it is rare. These effects usually stop after one - two weeks. Headaches and low white blood cell counts can also occur, but these are very rare. Anakinra should be used with caution in those with chronic kidney disease.

Anakinra is not specifically FDA approved for endometriosis. Although no data on its use in women with endometriosis have been published, there is no reason to expect women with endometriosis would be at any particular or increased risk than those in the general population.

This study is a randomized, double blinded, placebo controlled, cross-over clinical pilot study of 20 women. Patients diagnosed with laparoscopically proven endometriosis within the last 5 years will be randomized to either treatment with an FDA approved medication (Anakinra) or a placebo. This is an investigator initiated single center study sponsored by the Swedish Orphan Biovitrum (SOBI). SOBI will provide the study drug and placebo.

Keywords

Endometriosis Anakinra Markers of Inflammation Inflammation Interleukin 1 Receptor Antagonist Protein Anakinra 100Mg/0.67Ml Inj Syringe

Eligibility

You can join if…

Open to females ages 18-40

  • Women aged 18-40 with regular menstrual periods every 24-32 days and not lasting more than 6 days per month
  • Laparoscopically proven endometriosis within the last 5 years.
  • 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.
  • Off hormonal contraceptives for at least 1 month.
  • Off other hormonal therapy including depot provera (DMPA) for endometriosis for at least 3 months.
  • Willingness to use one of the following to prevent pregnancy:
  • Double method: barrier contraception with spermicide
  • IUD in place
  • Sterilization

You CAN'T join 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

Location

  • UCSD Reproductive Endocrinology not yet accepting patients
    La Jolla California 92037 United States

Lead Scientist

  • Sanjay K Agarwal, MD
    Clinical Professor, Reproductive Medicine. Authored (or co-authored) 52 research publications. Research interests: Infertility · PCOS · Endometriosis

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT03991520
Phase
Phase 1
Study Type
Interventional
Last Updated