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Combined Hormonal Contraceptive

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

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
Select...
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:
Select...
I have been diagnosed with metabolic syndrome.
Select...
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.
Select...
I do not have unmanaged health issues or recent major surgeries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Metabolic Syndrome
Secondary study objectives
Change in Ferriman-Gallwey Hirsutism score
Change in scoring on Polycystic Ovary Syndrome Quality of Life Questionnaire
Change in scoring on the Center for Epidemiologic Studies Depression Scale
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Contraceptive RingExperimental Treatment1 Intervention
Etonogestrel/ethinyl estradiol vaginal ring (NuvaRing), which releases 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily.

Find a Location

Who is running the clinical trial?

Andrea Roe, MD, MPHLead Sponsor
Andrea Roe, MD MPHPrincipal Investigator - University of Pennsylvania
University Of Pennsylvania School Of Medicine (Medical School)
~1 spots leftby Dec 2024
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