Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/Obese Women With PCOS (RING-PCOS)

This is an interventional prevention trial for Polycystic Ovary Syndrome Read More

Inclusion Criteria:

• Diagnosis of PCOS according to Rotterdam criteria, with at least 2 of 3 of the following criteria: oligomenorrhea (≤8 periods per year), clinical or biochemical hyperandrogenism, and polycystic ovaries on ultrasound
• Body mass index ≥25 and ≤45 kg/m2
• In good general health according to the investigators' discretion
• Willing to avoid pregnancy for the duration of the study

Exclusion Criteria:

• Current pregnancy or desire for pregnancy during course of study
• Current breastfeeding
• Second-trimester pregnancy within four weeks prior to initiation of NuvaRing or third-trimester pregnancy within 6 months prior to initiation of NuvaRing
• Use of hormonal contraception within four weeks prior to initiation of NuvaRing
• Diagnosis of metabolic syndrome. Metabolic syndrome will be defined according to the updated Adult Treatment Panel III as 3 or more of the following criteria: blood pressure ≥130/85 mm Hg, waist circumference >35 inches, fasting glucose ≥110 mg/dL, TG ≥150 mg/dL, HDL-C <50 mg/dL.

• Contraindications to NuvaRing use:

  • Age ≥ 35 plus tobacco use
  • Current or past deep vein thrombosis or pulmonary embolism
  • Cerebrovascular disease
  • Coronary artery disease
  • Thrombogenic valvular or rhythm diseases of the heart (such as subacute bacterial endocarditis with valvular disease or atrial fibrillation)
  • Inherited or acquired coagulopathy
  • Headaches with focal neurological symptoms or migraine headaches with aura
  • Age ≥ 35 plus any migraine headaches
  • Liver tumors, benign or malignant
  • Undiagnosed abnormal uterine bleeding
  • Current or past breast cancer or other estrogen- or progestin-sensitive cancer
  • Hypersensitivity to any of the components of NuvaRing
  • Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir

• Medical comorbidities:

  • 21-hydroxylase deficiency, congenital adrenal hyperplasia
  • Untreated thyroid disease
  • Untreated hyperprolactinemia
  • Type 1 or 2 diabetes mellitus
  • Uncontrolled liver disease
  • Uncontrolled renal disease
  • Current alcohol abuse
  • Hypertension ≥ 140 mm Hg average systolic or ≥ 90 mm Hg average diastolic in women using anti-hypertensive medication
  • Hypertension ≥ 150 mm Hg average systolic or ≥ 100 mm Hg average diastolic in women not using anti-hypertensive medication
  • History of or current gynecologic cancer
  • Triglycerides >=250 mg/dL
  • Current use of lipid-lowering or weight loss agents
  • Participation in any study of an investigational drug or device or biologic agent within 30 days
  • Suspected adrenal or ovarian tumor secreting androgens
  • Suspected Cushing's syndrome
  • Bariatric surgery within 12 months
  • Other medical concerns that in the judgment of the investigator may compromise safety of the participant or confound the reliability of compliance and information acquired in this study