Endometriosis Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | January 2022 |
Est. primary completion date | January 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UCSD Reproductive Endocrinology | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
Kennedy S, Bergqvist A, Chapron C, D'Hooghe T, Dunselman G, Greb R, Hummelshoj L, Prentice A, Saridogan E; ESHRE Special Interest Group for Endometriosis and Endometrium Guideline Development Group. ESHRE guideline for the diagnosis and treatment of endometriosis. Hum Reprod. 2005 Oct;20(10):2698-704. Epub 2005 Jun 24. — View Citation
Khanaki K, Nouri M, Ardekani AM, Ghassemzadeh A, Shahnazi V, Sadeghi MR, Darabi M, Mehdizadeh A, Dolatkhah H, Saremi A, Imani AR, Rahimipour A. Evaluation of the relationship between endometriosis and omega-3 and omega-6 polyunsaturated fatty acids. Iran Biomed J. 2012;16(1):38-43. — View Citation
Marik JJ. Leuprolide acetate depot and hormonal add-back in endometriosis: a 12-month study. Obstet Gynecol. 1998 May;91(5 Pt 1):793-4. — View Citation
Stratton P, Sinaii N, Segars J, Koziol D, Wesley R, Zimmer C, Winkel C, Nieman LK. Return of chronic pelvic pain from endometriosis after raloxifene treatment: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):88-96. doi: 10.1097/01.AOG.0000297307.35024.b5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the impact of anakinra versus placebo on menstrual pain (dysmenorrhea) using the modified Biberoglu and Behrman scale. | 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. | 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. | |
Secondary | Comparison of the impact of anakinra versus placebo on dyspareunia and non menstrual pelvic pain using the modified Biberoglu and Behrman scale. | Secondary pain outcome measures are to determine the impact of anakinra on dyspareunia and non-menstrual pelvic pain 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 dyspareunia and non-menstrual pelvic pain are secondary pain endpoints. | 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. | |
Secondary | Comparison of the impact of anakinra versus placebo on the quality of life using the Endometriosis Health Profile 30 questionnaire (EHP-30), conducted after each course of study medication administration. | The secondary outcome measure is to determine the impact of anakinra on the quality of life due to endometriosis, using the Endometriosis Health Profile 30 (EHP-30) questionnaire. The EHP-30 consists of a 30 item instrument that assesses pain, control and powerlessness, social support, emotional well-being, and self image. Each scale is standardized on a scale of 0 - 100, where 0 indicates the best health status through to 100 worst health status. | 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. | |
Secondary | Comparison of serum inflammatory markers before and after anakinra administration. | The secondary outcome is to evaluate the effect of anakinra on serum inflammatory markers that are elevated in women with endometriosis. Relevant inflammatory markers of endometriosis include CRP, CA125, IL-1, IL-4, IL-6, IL-10, BDNF, Glycodelin, and ZAG. There will be blood tests at the start and end of each of of the subject's next 6 menstrual periods: At the time of each blood draw, we will collect 20 mL (approximately 4 teaspoons) of blood. This will be needed for each of the 6 study menstrual periods for a total of 12 blood draws. There will be a total of 240 ml of blood or approximately 16 tablespoons of blood collected throughout the entire study. | There will be blood tests at the start and end of each of of the subject's next 6 menstrual periods for a total of 12 blood draws. |
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