Polycystic Ovary SyndromePhase 4RING-PCOSNCT04257500
Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/Obese Women With PCOS
A Phase 4 study testing Etonogestrel/ethinyl estradiol vaginal ring in people with Polycystic Ovary Syndrome, run by Andrea Roe, MD, MPH at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Etonogestrel/ethinyl estradiol vaginal ring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2020to 22 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 37Show fewer
- 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
- Medical comorbidities:
- 21-hydroxylase deficiency, congenital adrenal hyperplasia
- Untreated thyroid disease
- Untreated hyperprolactinemia
- Type 1 or 2 diabetes mellitus
- Uncontrolled liver disease
- Uncontrolled renal disease
- Current alcohol abuse
- Hypertension ≥ 140 mm Hg average systolic or ≥ 90 mm Hg average diastolic in women using anti-hypertensive medication
- Hypertension ≥ 150 mm Hg average systolic or ≥ 100 mm Hg average diastolic in women not using anti-hypertensive medication
- History of or current gynecologic cancer
- Triglycerides >=250 mg/dL
- Current use of lipid-lowering or weight loss agents
- Participation in any study of an investigational drug or device or biologic agent within 30 days
- Suspected adrenal or ovarian tumor secreting androgens
- Suspected Cushing's syndrome
- Bariatric surgery within 12 months
- Other medical concerns that in the judgment of the investigator may compromise safety of the participant or confound the reliability of compliance and information acquired in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Etonogestrel/ethinyl estradiol vaginal ring
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etonogestrel/ethinyl estradiol vaginal ringDrug
Also called NuvaRing
16 weeks of continuous use of contraceptive vaginal ring
| Study group | Role | What they receive |
|---|---|---|
| Contraceptive Ring | Experimental | Etonogestrel/ethinyl estradiol vaginal ring (NuvaRing), which releases 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily. Receives: Drug: Etonogestrel/ethinyl estradiol vaginal ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Metabolic Syndrome
Metabolic Syndrome 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.
Measured: 4 months
Secondary outcomes (15)
Change in low-density lipoprotein (LDL) measure
Measured: 4 months
Change in high-density lipoprotein (HDL) measure
Measured: 4 months
Change in triglycerides measure
Measured: 4 months
Change in apolipoprotein A
Measured: 4 months
Change in apolipoprotein B
Measured: 4 months
Change in advanced lipid testing measure
Measured: 4 months
Change in cholesterol efflux capacity
Measured: 4 months
Change in fasting insulin level
Measured: 4 months
Change in fasting 2 hour oral Glucose Tolerance Test result
Measured: 4 months
Change in Testosterone
Measured: 4 months
Change in Ferriman-Gallwey Hirsutism score
A lower score indicates less hirsutism. The F-G scoring system has a minimum value of 0, and a maximum value of 36.
Measured: 4 months
Body Mass Index
Measured: 4 months
Change in scoring on the Center for Epidemiologic Studies Depression Scale
The range of values is zero to 60, with the higher scores indicating the presence of more depressive symptoms.
Measured: 4 months
Change in scoring on the State-Trait Anxiety Inventory
The State-Trait Anxiety Inventory measures both state and trait anxiety, the scores range from 20 to 80, with higher scores correlating with greater anxiety.
Measured: 4 months
Change in scoring on Polycystic Ovary Syndrome Quality of Life Questionnaire
Worse quality of life is associated with a lower score on the questionnaire, with a range score from 30 to 210.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start3 Sep 2020
- Primary completion22 Aug 2025
- Study completion22 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrea Roe, MD, MPH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrea Roe, MD, MPH, University of Pennsylvania
- Investigators
- Andrea Roe, MD MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257500
- Sponsor's protocol ID
- 834422
- Acronym
- RING-PCOS
- Status last verified
- Dec 2025
- First submitted
- 31 Jan 2020
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/Obese Women With PCOS
- ClinicalTrials.gov ID
- NCT04257500
- Acronym / sponsor ID
- RING-PCOS / 834422
- Conditions
- Polycystic Ovary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Andrea Roe, MD, MPHUniversity, hospital or other
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 22 Aug 2025 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contraceptive Ring | Experimental | Drug: Etonogestrel/ethinyl estradiol vaginal ringEtonogestrel/ethinyl estradiol vaginal ring (NuvaRing), which releases 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (37 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etonogestrel/ethinyl estradiol vaginal ringAlso: NuvaRing16 weeks of continuous use of contraceptive vaginal ring | Drug | Contraceptive Ring |
Primary outcome
Incidence of Metabolic Syndrome
Time frame: 4 months
Metabolic Syndrome 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.
15 secondary outcomes
Change in low-density lipoprotein (LDL) measure
Time frame: 4 months
Change in high-density lipoprotein (HDL) measure
Time frame: 4 months
Change in triglycerides measure
Time frame: 4 months
Change in apolipoprotein A
Time frame: 4 months
Change in apolipoprotein B
Time frame: 4 months
Change in advanced lipid testing measure
Time frame: 4 months
Change in cholesterol efflux capacity
Time frame: 4 months
Change in fasting insulin level
Time frame: 4 months
Change in fasting 2 hour oral Glucose Tolerance Test result
Time frame: 4 months
Change in Testosterone
Time frame: 4 months
Change in Ferriman-Gallwey Hirsutism score
Time frame: 4 months
Body Mass Index
Time frame: 4 months
Change in scoring on the Center for Epidemiologic Studies Depression Scale
Time frame: 4 months
Change in scoring on the State-Trait Anxiety Inventory
Time frame: 4 months
Change in scoring on Polycystic Ovary Syndrome Quality of Life Questionnaire
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Roe, MD MPH principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etonogestrel/ethinyl estradiol vaginal ring in people with Polycystic Ovary Syndrome, run by Andrea Roe, MD, MPH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Metabolic Syndrome (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.