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

• Status: Completed
• Trial end date: 2020-07-30
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Treatments: Interleukin 1 Receptor Antagonist Protein; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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