Impact of a Vaginal Contraceptive Ring on Metabolic Health in Overweight Women with PCOS
Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/obese Women with PCOS
This study is testing whether a vaginal contraceptive ring can improve metabolic health in overweight women with PCOS.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04257500 on ClinicalTrials.gov |
What this trial studies
This study investigates the metabolic effects of a vaginal contraceptive ring containing etonogestrel and ethinyl estradiol in overweight and obese women diagnosed with polycystic ovary syndrome (PCOS). A total of 40 participants will be recruited to use the vaginal ring over a 4-month period, with the aim of assessing its influence on the risk of developing metabolic syndrome. The study follows a prospective design to gather data on metabolic changes associated with this contraceptive method.
Who should consider this trial
Good fit: Ideal candidates for this study are overweight or obese women aged 18-40 with a confirmed diagnosis of PCOS.
Not a fit: Patients who are currently pregnant, breastfeeding, or have a diagnosis of metabolic syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into safer contraceptive options that may also improve metabolic health for women with PCOS.
How similar studies have performed: While there is limited data on the specific use of vaginal contraceptive rings in this population, similar studies have explored hormonal contraceptives' effects on metabolic health, indicating potential for beneficial outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Andrea Roe, MD MPH — University of Pennsylvania
- Study coordinator: Andrea Morley
- Email: andrea.morley@pennmedicine.upenn.edu
- Phone: 215-615-4202
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.