Effects of Interleukin-1 Receptor Antagonism on Hyperandrogenemia in Women With Polycystic Ovary Syndrome

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

• 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