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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

RING-PCOS Trial 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.Check my eligibility
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.See study design
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.

RING-PCOS Trial 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.

RING-PCOS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Metabolic Syndrome
Secondary outcome measures
Body Mass Index
Change in Ferriman-Gallwey Hirsutism score
Change in Testosterone
+12 more

RING-PCOS 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)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/Obese Women With PCOS
Andrea Roe, MD, MPH 2020. "Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/Obese Women With PCOS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04257500.
All > Metabolic Syndrome > Overweight
~2 spots leftby Jul 2024
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