Clinical trial · Interventional
Effects of Interleukin-1 Receptor Antagonism on Hyperandrogenemia in Women With Polycystic Ovary Syndrome
Effects of Interleukin-1 Receptor Antagonism on Hyperandrogenemia in Women With Polycystic Ovary Syndrome - a Prospective, Interventional, Single-arm, Open-label, Proof-of-concept Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IL-1 receptor antagonist Anakinra | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IL-1 receptor antagonist Anakinra 100 mg
- 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.
- interventionNames
- Drug: IL-1 receptor antagonist Anakinra
Primary outcomes (1)
- measure
- Absolute change in fasting serum androstenedione level (nmol/l) from start (baseline, day 1) to one week after treatment start with Anakinra.
- timeFrame
- 7 days
- description
- Absolute change in fasting serum androstenedione level (nmol/l) from start (baseline, day 1) to one week after treatment start with Anakinra.
Secondary outcomes (15)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available