NCT04257500

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2020

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

September 3, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

5 years

First QC Date

January 31, 2020

Last Update Submit

December 15, 2025

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 months

Secondary Outcomes (15)

  • Change in low-density lipoprotein (LDL) measure

    4 months

  • Change in high-density lipoprotein (HDL) measure

    4 months

  • Change in triglycerides measure

    4 months

  • Change in apolipoprotein A

    4 months

  • Change in apolipoprotein B

    4 months

  • +10 more secondary outcomes

Study Arms (1)

Contraceptive Ring

EXPERIMENTAL

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

Drug: Etonogestrel/ethinyl estradiol vaginal ring

Interventions

Etonogestrel/ethinyl estradiol vaginal ringDRUG

16 weeks of continuous use of contraceptive vaginal ring

Also known as: NuvaRing
Contraceptive Ring

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

etonogestrelNuvaRing

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Andrea Roe, MD MPH

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 6, 2020

Study Start

September 3, 2020

Primary Completion

August 22, 2025

Study Completion

August 22, 2025

Last Updated

December 17, 2025

Record last verified: 2025-12

Locations

US(1)