Last updated on October 2018

Effects of IL-1 Receptor Antagonism on Testosterone Production in Women With Polycystic Ovary Syndrome

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Polycystic Ovary Syndrome
  • Age: Between 18 - 100 Years
  • Gender: Female

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 criteria11
  • High sensitivity C-reactive protein level 2 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 3 months 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, Intention to become pregnant during the course of the study,
  • Lack of safe contraception
  • 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
  • Hematologic disease (leukocyte count < 1.5 x 109/l, haemoglobin < 11 g/dl, platelets <100 x 103/l),
  • Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, active carcinoma),
  • History of or suspected tuberculosis and/or hepatitis B/C

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.