Overview
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
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