Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in… (NCT04257500) | Clinical Trial Compass
CompletedPhase 4
Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/Obese Women With PCOS
United States22 participantsStarted 2020-09-03
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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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…