Vaginal ring tested for safety in overweight PCOS women
NCT ID NCT04257500
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether using a contraceptive vaginal ring (NuvaRing) for 16 weeks affects the risk of metabolic syndrome in overweight or obese women with polycystic ovary syndrome (PCOS). Researchers enrolled 22 participants and measured changes in blood pressure, waist size, blood sugar, and cholesterol. The goal was to see if this birth control method is safe for this specific group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- etonogestrel/ethinyl estradiol vaginal ring (NuvaRing)
- What this could lead to
- If successful, this could show that the vaginal ring is a safe contraceptive option for overweight/obese women with PCOS without raising metabolic syndrome risk.
- What could go wrong
- This was a small, completed Phase 4 study with only 22 participants, so results may not apply to all women. The ring may still affect cholesterol or blood pressure in some individuals.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
22 people
The number who actually took part.
- Started
-
Sep 2020
- Finished
-
Aug 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 40 years
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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Other studies related to the condition(s) this trial covers.
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