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A prospective, interventional, open-label, single-arm, proof-of-concept study: 18 women with Polycystic Ovary Syndrome (PCOS) will be treated with 100 mg of Anakinra/Kineret® for 4 weeks. 1 week after last injection patients will have a follow-up and a dexamethasone visit after a dexamethasone suppression test. Goal of this study is to investigate the effect of the Interleukin 1( IL-1) receptor antagonist Anakinra/Kineret® on laboratory and clinical features in women with PCOS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IL-1 receptor antagonist Anakinra 100 mg | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IL-1 receptor antagonist Anakinra | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in fasting serum androstenedione level (nmol/l) from start (baseline, day 1) to one week after treatment start with Anakinra. | Absolute change in fasting serum androstenedione level (nmol/l) from start (baseline, day 1) to one week after treatment start with Anakinra. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ferriman-Gallwey-score | 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 |
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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
Follicular phase of menstrual cycle as evident by
Willingness to use non-hormonal contraceptive measures adequate to prevent becoming pregnant during the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mirjam Christ-Crain, Prof. Dr. MD | University Hospital Basel, Dep. of Endocrinology, Diabetes and Metabolism | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel Endocrinology, Diabetes and Metabolism | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Day 1 and 28 |
| Sebum production measures | Effect of Anakinra/Kineret® on sebum production will be assessed with Sebumeter® SM 815, Courage + Khazaka electronic Gesellschaft mit beschränkter Haftung (GmbH) | At day 1 and 28 |
| Self-reported frequency of hair removal (times/week) | Effect of Anakinra/Kineret® on hirsutism will be assessed | At day 1 and 28 |
| Plewig-Kligman-score | 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. | At day 1 and 28 |
| Ovulation and menstruation rates [%] | Effect of Anakinra/Kineret® on ovulation and menstruation rates will be assessed | Between day 1 and day 35 |
| 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) | Effect of Anakinra/Kineret® on peripheral (sexual) hormones will be assessed | Day 1, 7, 14, 21, 28 and 35 |
| Fasting glucose (mmol/l), homeostatic model of assessment of insulin resistance (HOMA-IR) | Effect of Anakinra/Kineret® on glucose metabolism will be assessed | At day 1, 7, 14, 21, 28 and 35 |
| Pituitary hormones (luteinizing hormone (LH), follicle stimulating hormone (FSH), adrenocorticotropic hormone (ACTH) [IU/L]) | Effect of Anakinra/Kineret® on the pituitary-gonadal axis will be assessed | Day 1, 7, 14, 21, 28 and 35 |
| Treatment response according to a Dexamethasone suppression test | Dexamethasone suppression test will be evaluated as a predictor for treatment response | At days 35 and 36 |
| inflammatory marker white blood cell count [x109/l], | Time course of inflammatory marker white blood cell count [x109/l] will be assessed | Day 1, 7, 14, 21, 28 and 35 |
| inflammatory marker C reactive protein (CRP) [mg/l] | Time course of inflammatory marker CRP [mg/l] will be assessed | Day 1, 7, 14, 21, 28 and 35 |
| inflammatory marker IL-6 [pg/ml] | Time course of inflammatory marker IL-6 [pg/ml] will be assessed | Day 1 and 28 |
| inflammatory marker IL-1Ra [pg/ml] | Time course of inflammatory marker IL-1Ra [pg/ml] will be assessed | Day 1, 7, 14, 21, 28 and 35 |
| 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 androstenedione level (nmol/l) from start (baseline, day 1) to days 14, 21, 28, and 35 after treatment start with Anakinra. | 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 | 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 | Days 7, 14, 28, and 35 after treatment start with Anakinra |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D011506 | Proteins |
| D001685 | Biological Factors |