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

NCT04257500 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-12-17

No results posted yet for this study

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

Interventions

DRUG

Etonogestrel/ethinyl estradiol vaginal ring

16 weeks of continuous use of contraceptive vaginal ring

Sponsors & Collaborators

  • Andrea Roe, MD, MPH

    lead OTHER

Principal Investigators

  • Andrea Roe, MD MPH · University of Pennsylvania

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-03
Primary Completion
2025-08-22
Completion
2025-08-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04257500 on ClinicalTrials.gov