Suspended

The Effects of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring (NuvaRing®) on Vaginal Innate and Inflammatory Biomarkers

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What is being tested

Etonogestrel /Ethinyl Estradiol Contraceptive Vaginal Ring

Drug
Who is being recruted

Urogenital Diseases+8

+ Genital Diseases

+ Bacterial Infections and Mycoses

From 18 to 45 Years
+32 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: October 2011
See protocol details

Summary

Principal SponsorEastern Virginia Medical School
Study ContactJulia Caul
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2011

Actual date on which the first participant was enrolled.

1. To complete specific aim #1, the investigators will use commercially available elisa kits to measure human defensins, inflammatory cytokines, and anti-inflammatory cytokines in vaginal fluid washings collected before and after use of NuvaRing. 2. To complete specific aim #2, the investigators will collect biopsies of the uterine cervix before and after NuvaRing use. Specimens will undergo histopathological measures for overall appearance, epithelial integrity, epithelial thickness, leukocyte infiltration, congestion, and edema. The investigators will quantitate the number of CD45+ and NFkB+ cells using immunohistology in the cervical epithelium.

Official TitleThe Effects of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring (NuvaRing®) on Vaginal Innate and Inflammatory Biomarkers
NCT01448291
Principal SponsorEastern Virginia Medical School
Study ContactJulia Caul
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesBacterial Infections and MycosesBacterial InfectionsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleInfectionsVaginal DiseasesVaginitisVaginosis, BacterialFemale Urogenital Diseases

Criteria

5 inclusion criteria required to participate
Women (age 18 - 45) interested in using NuvaRing® for contraception for 3 or more months, and women who are not at risk for pregnancy (i.e. abstinent, tubal sterilization, partner with vasectomy)
Women with a normal menstrual cycle (21-35 days) for the past three cycles
Women with normal pelvic anatomy (by physical exam)
Negative urine pregnancy test
Show More Criteria
27 exclusion criteria prevent from participating
Hysterectomy
Current breastfeeding
Pregnancy
Less than 6 weeks post partum
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
This is a single-group study in which data points after use of the etonogestrel/ethinyl estradiol vaginal ring will be compared to baseline.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Clinical Research Center at Eastern Virginia Medical School

Norfolk, United StatesOpen Clinical Research Center at Eastern Virginia Medical School in Google Maps
SuspendedOne Study Center