Vaginal Hormonal Contraception for PCOS (RING-PCOS Trial)

Phase 4

Recruiting

Led By Andrea Roe, MD MPH

Research Sponsored by Andrea Roe, MD, MPH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be between 18 and 65 years old

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial will study the effects of the contraceptive vaginal ring on overweight and obese women with PCOS.

Who is the study for?

This trial is for overweight or obese women with PCOS who are in good health and not currently pregnant, breastfeeding, or wishing to become pregnant soon. They must have a BMI between 25 and 45 kg/m2 and meet two of three specific criteria related to PCOS. Women over 35 who smoke or have certain medical conditions like uncontrolled blood pressure, liver disease, or history of clotting disorders cannot participate.

What is being tested?

The study is testing the effects of a contraceptive vaginal ring on metabolic factors in women with PCOS over four months. It aims to recruit 40 participants to see if this method affects their risk of developing metabolic syndrome.

What are the potential side effects?

Potential side effects from using the etonogestrel/ethinyl estradiol vaginal ring may include headaches, nausea, breast tenderness, mood changes, weight gain, menstrual changes such as spotting or irregular bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have PCOS with at least 2 symptoms: irregular periods, high androgen levels, or polycystic ovaries.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with metabolic syndrome.

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Criterion: You cannot participate if you are over 35 years old and use tobacco, have a history of blood clots, certain heart conditions, certain types of headaches, liver tumors, undiagnosed abnormal uterine bleeding, certain types of cancer, or are allergic to any components of NuvaRing.

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I do not have unmanaged health issues or recent major surgeries.