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

University Hospital Basel

Status and phase: Completed; Phase 2

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: IL-1 receptor antagonist Anakinra

Study type: Interventional

Funder types: Other

Identifiers

NCT03578497

2018-00780 me16CC6;

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

IL-1 receptor antagonist Anakinra 100 mg

Experimental group

Description:

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.

Treatment:

Drug: IL-1 receptor antagonist Anakinra