does vaginal delivery of combined hormonal contraception affect the risk of metabolic syndrome in overweight/obese women with pcos

Conditions: Polycystic Ovary Syndrome

Summary: 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.


Eligibility criteria:
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