Effects of Interleukin-1 Receptor Antagonism on Hyperandrogenemia in Women With Polycystic Ovary Syndrome (FertIL)
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ClinicalTrials.gov Identifier: NCT03578497 |
Recruitment Status :
Completed
First Posted : July 6, 2018
Last Update Posted : January 27, 2021
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Condition or disease | Intervention/treatment | Phase |
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Polycystic Ovary Syndrome | Drug: IL-1 receptor antagonist Anakinra | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effects of Interleukin-1 Receptor Antagonism on Hyperandrogenemia in Women With Polycystic Ovary Syndrome - a Prospective, Interventional, Single-arm, Open-label, Proof-of-concept Study |
Actual Study Start Date : | August 31, 2018 |
Actual Primary Completion Date : | July 30, 2020 |
Actual Study Completion Date : | July 30, 2020 |

Arm | Intervention/treatment |
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Experimental: IL-1 receptor antagonist Anakinra 100 mg
Anakinra (Kineret®; r-metHuIL-1ra, Swedish Orphan Biovitrum AB) is a recombinant, non-glycosylated form of the human IL-1Ra in a 100 mg/ 0.67 ml solution for subcutaneous injection. Anakinra/Kineret® is supplied in single use prefilled glass syringes with 27 gauge needles as a sterile, clear, colorless-to-white, preservative free solution for daily s.c. administration over a time period of 28 days.
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Drug: IL-1 receptor antagonist Anakinra
IL-1 receptor antagonist Anakinra is a recombinant, non-glycosylated form of the human IL-1Ra in a 100 mg/ 0.67 ml solution for subcutaneous injection. Standard dosage licensed by the FDA and European Medicines Agency (EMA) is 100 mg Anakinra daily. It is supplied in single use prefilled glass syringes with 27 gauge needles as a sterile, clear, colourless-to-white, preservative free solution for daily s.c. administration.
Other Name: Kineret |
- Absolute change in fasting serum androstenedione level (nmol/l) from start (baseline, day 1) to one week after treatment start with Anakinra. [ Time Frame: 7 days ]Absolute change in fasting serum androstenedione level (nmol/l) from start (baseline, day 1) to one week after treatment start with Anakinra.
- Ferriman-Gallwey-score [ Time Frame: Day 1 and 28 ]Effect of Anakinra/Kineret® on hirsutism by Ferriman-Gallwey-score (representation of hair growth in a male pattern on a woman shown in four different degrees of severity ( 0= no hair growth; 1= light hair growth; 2= moderate hair growth; 4= severe hair growth) in 11 different body parts; namely the upper lip, chin, chest, upper back, lower back, upper abdomen, lower abdomen, arm, forearm, thigh, and lower leg) will be assessed
- Sebum production measures [ Time Frame: At day 1 and 28 ]Effect of Anakinra/Kineret® on sebum production will be assessed with Sebumeter® SM 815, Courage + Khazaka electronic Gesellschaft mit beschränkter Haftung (GmbH)
- Self-reported frequency of hair removal (times/week) [ Time Frame: At day 1 and 28 ]Effect of Anakinra/Kineret® on hirsutism will be assessed
- Plewig-Kligman-score [ Time Frame: At day 1 and 28 ]Effect of Anakinra/Kineret® on acne severity, assessed with Plewig-Kligman score (presentation of comedonal and inflammatory acne severity, separately graded based on the number of lesions and type; lesion counting done at right side of the face, excluding other side, chest and back.
- Ovulation and menstruation rates [%] [ Time Frame: Between day 1 and day 35 ]Effect of Anakinra/Kineret® on ovulation and menstruation rates will be assessed
- Estradiol (pmol/l), free testosterone (nmol/l), total testosterone (nmol/l), sex hormone-binding globulin (SHBG) [nmol/l], Anti-Muellerian Hormone [pmol/l], dehydroepiandrosterone (DHEA) [nmol/l]), basal cortisol (nmol/l) [ Time Frame: Day 1, 7, 14, 21, 28 and 35 ]Effect of Anakinra/Kineret® on peripheral (sexual) hormones will be assessed
- Fasting glucose (mmol/l), homeostatic model of assessment of insulin resistance (HOMA-IR) [ Time Frame: At day 1, 7, 14, 21, 28 and 35 ]Effect of Anakinra/Kineret® on glucose metabolism will be assessed
- Pituitary hormones (luteinizing hormone (LH), follicle stimulating hormone (FSH), adrenocorticotropic hormone (ACTH) [IU/L]) [ Time Frame: Day 1, 7, 14, 21, 28 and 35 ]Effect of Anakinra/Kineret® on the pituitary-gonadal axis will be assessed
- Treatment response according to a Dexamethasone suppression test [ Time Frame: At days 35 and 36 ]Dexamethasone suppression test will be evaluated as a predictor for treatment response
- inflammatory marker white blood cell count [x109/l], [ Time Frame: Day 1, 7, 14, 21, 28 and 35 ]Time course of inflammatory marker white blood cell count [x109/l] will be assessed
- inflammatory marker C reactive protein (CRP) [mg/l] [ Time Frame: Day 1, 7, 14, 21, 28 and 35 ]Time course of inflammatory marker CRP [mg/l] will be assessed
- inflammatory marker IL-6 [pg/ml] [ Time Frame: Day 1 and 28 ]Time course of inflammatory marker IL-6 [pg/ml] will be assessed
- inflammatory marker IL-1Ra [pg/ml] [ Time Frame: Day 1, 7, 14, 21, 28 and 35 ]Time course of inflammatory marker IL-1Ra [pg/ml] will be assessed
- Change in androstenedione level (nmol/l) from start (baseline, day 1) to days 14, 21, 28, and 35 after treatment start with Anakinra. [ Time Frame: Days 14, 21, 28, and 35 after treatment start with Anakinra ]Change in androstenedione level (nmol/l) from start (baseline, day 1) to days 14, 21, 28, and 35 after treatment start with Anakinra.
- Change in 11-oxygenated androgens (e.g. 11-ketotestosterone, 11-ketoandrostenedione, 11β-hydroxytestosterone, 11β-hydroxyandrostenedione [nmol/l]) on days 7, 14, 28, and 35 after treatment start with Anakinra [ Time Frame: Days 7, 14, 28, and 35 after treatment start with Anakinra ]Change in 11-oxygenated androgens (e.g. 11-ketotestosterone, 11-ketoandrostenedione, 11β-hydroxytestosterone, 11β-hydroxyandrostenedione [nmol/l]) on days 7, 14, 28, and 35 after treatment start with Anakinra

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Informed Consent as documented by signature
- Premenopausal women aged 18 years or older
- Onset of menarche ≥5 years ago
- Diagnosis of PCOS defined by the Rotterdam criteria
- High sensitivity C-reactive protein level ≥1 mg/l
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Follicular phase of menstrual cycle as evident by
- Serum estradiol level <200 pmol/l AND
- Serum progesterone level <8 ng/ml
- Willingness to use non-hormonal contraceptive measures adequate to prevent becoming pregnant during the study
Exclusion Criteria:
- Intake of any testosterone level modifying drugs in the 8 weeks prior to study inclusion,
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to Anakinra/Kineret,
- Women who are pregnant or breast feeding,
- Female participants who are ovariectomized or hysterectomised or post-menopausal
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Previous enrolment into the current study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons,
- Clinical signs of infection in the week before inclusion or history of a severe infection during the last 2 months,
- Potentially severe immunosuppression or intake of other immunosuppressive drugs
- Severe hematologic disease
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, active carcinoma),
- History of or suspected tuberculosis and/or hepatitis B/C

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578497
Switzerland | |
University Hospital Basel Endocrinology, Diabetes and Metabolism | |
Basel, Switzerland, 4031 |
Principal Investigator: | Mirjam Christ-Crain, Prof. Dr. MD | University Hospital Basel, Dep. of Endocrinology, Diabetes and Metabolism |
Responsible Party: | University Hospital, Basel, Switzerland |
ClinicalTrials.gov Identifier: | NCT03578497 |
Other Study ID Numbers: |
2018-00780; me16CC6 |
First Posted: | July 6, 2018 Key Record Dates |
Last Update Posted: | January 27, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Interleukin-1 receptor antagonism Kineret/Anakinra testosteron hyperandrogenemia androstenedione |
Polycystic Ovary Syndrome Syndrome Disease Pathologic Processes Ovarian Cysts Cysts Neoplasms |
Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases Interleukin 1 Receptor Antagonist Protein Antirheumatic Agents |