Effects of Interleukin-1 Receptor Antagonism on Hyperandrogenemia in Women With Polycystic Ovary … (NCT03578497) | Clinical Trial Compass
CompletedPhase 2
Effects of Interleukin-1 Receptor Antagonism on Hyperandrogenemia in Women With Polycystic Ovary Syndrome
Switzerland18 participantsStarted 2018-08-31
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 immunosup…
What they're measuring
1
Absolute change in fasting serum androstenedione level (nmol/l) from start (baseline, day 1) to one week after treatment start with Anakinra.