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

NCT ID: NCT03578497

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-31
• Study Completion Date: 2020-07-30

Brief 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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

IL-1 receptor antagonist Anakinra

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Kineret

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mirjam Christ-Crain, Prof. Dr. MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Dep. of Endocrinology, Diabetes and Metabolism

Locations

University Hospital Basel Endocrinology, Diabetes and Metabolism

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

2018-00780; me16CC6

Identifier Type: -

Identifier Source: org_study_id