Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/Obese Women With PCOS

NCT ID: NCT04257500

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-03
• Study Completion Date: 2025-08-22

Brief 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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Contraceptive Ring

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

Group Type: EXPERIMENTAL

Etonogestrel/ethinyl estradiol vaginal ring

Intervention Type: DRUG

16 weeks of continuous use of contraceptive vaginal ring

Interventions

Etonogestrel/ethinyl estradiol vaginal ring

16 weeks of continuous use of contraceptive vaginal ring

Intervention Type: DRUG

Other Intervention Names

NuvaRing

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Andrea Roe, MD, MPH

OTHER

Sponsor Role: lead

Responsible Party

Andrea Roe, MD, MPH

Assistant Professor of Obstetrics and Gynecology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrea Roe, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

834422

Identifier Type: -

Identifier Source: org_study_id