Vaginal Hormonal Contraception for PCOS

(RING-PCOS Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Andrea Roe, MD MPH

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Andrea Roe, MD, MPH

Must not be taking: Hormonal contraception, Lipid-lowering agents

Disqualifiers: Pregnancy, Metabolic syndrome, Diabetes, Hypertension, Cancer, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop using hormonal contraception at least four weeks before starting the study. If you are using lipid-lowering or weight loss medications, you will also need to stop those. For other medications, the protocol does not specify, so it's best to discuss with the study team.

What data supports the effectiveness of the drug Etonogestrel/ethinyl estradiol vaginal ring for PCOS?

The contraceptive vaginal ring, which releases ethinyl estradiol and etonogestrel, has been shown to provide effective cycle control and symptom relief for women with polycystic ovarian syndrome (PCOS). Studies indicate that its efficacy and safety are equivalent to oral contraceptives, with users reporting high satisfaction and fewer side effects. ^{1 2 3 4 5}

Is the vaginal hormonal contraception ring safe for humans?

The safety of the vaginal hormonal contraception ring, known by names like NuvaRing and EluRyng, has been evaluated in various studies. It is generally considered safe for use in humans, although, like all medications, it may have some side effects. Always consult with a healthcare provider for personalized advice. ^{6 7 8 9 10}

How does the drug Etonogestrel/ethinyl estradiol vaginal ring differ from other treatments for PCOS?

The Etonogestrel/ethinyl estradiol vaginal ring is unique because it is a hormonal contraceptive delivered through a vaginal ring, providing a steady release of hormones directly absorbed through the vaginal lining, which may result in fewer systemic side effects compared to oral contraceptives. This method can offer effective cycle control and symptom relief for women with polycystic ovarian syndrome (PCOS), and some women may prefer it for its convenience and reduced metabolic effects. ^{1 2 3 4 5}

Research Team

Andrea Roe, MD MPH

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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.

Inclusion Criteria

Willing to avoid pregnancy for the duration of the study

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

You weigh between 55 and 99 pounds and are not too underweight or overweight.

Exclusion Criteria

I have been diagnosed with metabolic syndrome.

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.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the contraceptive vaginal ring for a 4-month period to study its metabolic effects

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Etonogestrel/ethinyl estradiol vaginal ring (Combined Hormonal Contraceptive)

Trial Overview 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.

Participant Groups

Group I: Contraceptive Ring Experimental Treatment 1 Intervention

Etonogestrel/ethinyl estradiol vaginal ring (NuvaRing), which releases 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily.

Etonogestrel/ethinyl estradiol vaginal ring is already approved in Canada for the following indications:

Approved in Canada as NuvaRing for:

• Contraception

Who Is Running the Clinical Trial?

Andrea Roe, MD, MPH

Lead Sponsor

Trials

1

Recruited

30+

References

1. France pubmed.ncbi.nlm.nih.gov

Ethinylestradiol + etonogestrel contraceptive vaginal ring: new drug. Possibly useful in some situations. [2013]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of etonogestrel and ethinylestradiol released from a combined contraceptive vaginal ring. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Contraceptive vaginal ring use for women has less adverse metabolic effects than an oral contraceptive. [2007]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of uterine concentrations of ethinyl estradiol and etonogestrel after use of a contraceptive vaginal ring and an oral contraceptive. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Vaginal ring contraception. [2014]

6. Germany pubmed.ncbi.nlm.nih.gov

Safety and pharmacokinetic evaluation of repeated intravenous administration of palonosetron 0.75 mg in patients receiving highly or moderately emetogenic chemotherapy. [2021]

7. China pubmed.ncbi.nlm.nih.gov

Megestrol acetate dispersible tablets with a 5-HT3 receptor antagonist and dexamethasone vs. 5-HT3 receptor antagonist plus dexamethasone, can better control chemotherapy-induced nausea and vomiting: a randomized controlled study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Safety of clinical practice guideline-recommended antiemetic agents for the prevention of acute chemotherapy-induced nausea and vomiting in pediatric patients: a systematic review and meta-analysis. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Comparison of Ramosetron with Palonosetron for Prevention of Postoperative Nausea and Vomiting in Patients Receiving Opioid-Based Intravenous Patient-Controlled Analgesia after Gynecological Laparoscopy. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and safety of triple therapy with aprepitant, palonosetron, and dexamethasone for preventing nausea and vomiting induced by cisplatin-based chemotherapy for gynecological cancer: KCOG-G1003 phase II trial. [2022]