Last updated on November 2019

Treating Inflammation in Polycystic Ovary Syndrome to Ameliorate Ovarian Dysfunction

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 - 40 Years
  • Gender: Female

Inclusion Criteria:

  • Diagnosis of PCOS based on the presence of hyperandrogenism (skin manifestations of androgen excess such as hirsutism, acne or temporal balding or elevation of at least one serum androgen [i.e. total testosterone, free testosterone, androstenedione or dehydroepiandrosterone-sulphate] using predetermined local laboratory cutoffs), oligo/amenorrhea and evidence of withdrawal bleeding after progestin administration.
  • 18-40 years of age.
  • Good health as evidenced by medical history, physical examination and gynecologic examination within 30 days prior to starting the study.
  • Willingness to provide informed consent according to the guidelines of the University of Illinois at Chicago (UIC) Institutional Review Board (IRB).
  • Willingness to use double-barrier contraception such as condoms and topical spermicide (foam, cream or gel), condom and diaphragm, diaphragm and topical spermicide or sponge with topical spermicide if sexually active. Use of a non-hormonal intrauterine device (IUD), or permanent sterilization of the subject or her partner (i.e. tubal ligation or vasectomy) is also acceptable in all instances.

Exclusion Criteria:

  • Hyperprolactinemia.
  • Uncontrolled thyroid disease.
  • Evidence of Cushing's syndrome, nonclassic congenital adrenal hyperplasia or a hormone producing tumor based on physical findings and serum androgen levels on initial screening.
  • Known or suspected pregnancy.
  • Regular vigorous physical activity during previous 6 months.
  • Use of any medications known to affect carbohydrate or sex hormone metabolism such as oral contraceptives, progestins, glucocorticoids or insulin sensitizing agents within 30 days of beginning the study.
  • Acute or chronic inflammatory illnesses (e.g. upper respiratory infection, asthma, rheumatoid arthritis or systemic lupus erythematosus).
  • Type 1 or type 2 diabetes mellitus defined as having a fasting glucose >126 mg/dl and/or a 2-hour postprandial glucose >200 mg/dl.
  • Regular smoking defined as more than 2 cigarettes a month, or any smoking within 30 days of beginning the study.
  • History of any illness exacerbated by salicylate use (e.g. peptic ulcer hepatic or renal disease, anemia, thrombosis, coagulopathy, congestive heart failure, hypertension or gout).
  • Allergy to salicylate or dairy products.
  • Medication use interacting with salicylates such as anti-platelet drugs (e.g. cilostazol, clopidogrel), anticoagulants (e.g. enoxaparin, heparin, warfarin), corticosteroids (e.g., prednisone), certain diabetes drugs (e.g. sulfonylureas such as glyburide), certain anti-seizure drugs (e.g. phenytoin, valproic acid), cidofovir, cyclosporine, drugs for gout (e.g. probenecid, sulfinpyrazone), anti-hypertensives (e.g. angiotensin converting enzyme inhibitors such as captopril, angiotensin II receptor antagonists such as losartan, and beta blockers such as metoprolol), drugs that affect the acidity of urine (e.g. ammonium chloride, acetazolamide), lithium, methotrexate, oral bisphosphonates (e.g. alendronate), pemetrexed, selective serotonin reuptake inhibitor antidepressants (e.g. fluoxetine, sertraline), tenofovir, and diuretics (furosemide, hydrochlorothiazide, spironolactone).

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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