Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/Obese Women With PCOS
Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/Obese Women With PCOS
A prospective study to determine the metabolic effects of the contraceptive vaginal ring
 among overweight and obese women with polycystic ovary syndrome (PCOS). We will recruit a
 total of 40 participants and study use of the vaginal ring over a 4-month period.
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