Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Andrea Roe, MD, MPH
Age
18–40
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
* 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
