Clinical trial · Interventional
Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/Obese Women With PCOS
NCT04257500CI-TRIAL-00099137RING-PCOScompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etonogestrel/ethinyl estradiol vaginal ring | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Contraceptive Ring
- description
- Etonogestrel/ethinyl estradiol vaginal ring (NuvaRing), which releases 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily.
- interventionNames
- Drug: Etonogestrel/ethinyl estradiol vaginal ring
Primary outcomes (1)
- measure
- Incidence of Metabolic Syndrome
- timeFrame
- 4 months
- description
- 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.
Secondary outcomes (15)
- measure
- Change in low-density lipoprotein (LDL) measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.