Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity

November 16, 2021 updated by: Christine Johnston, University of Washington
To assess potential benefits associated with both intermittent (use for 3 weeks, remove for 1 week, as defined in the package insert) and continuous (use for 4 weeks, then replace) CVR use among women either with BV or at high risk for BV. The investigators will also recruit women who are HSV2-infected.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • UW Virology Research Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ≥18-40 year old women
  • BV+ by Amsel criteria and Nugent score OR history of BV in the prior 6 months
  • Willing to use the NuvaRing as directed
  • Not intending or wishing to become pregnant over the course of the study
  • Capable of providing written informed consent

Exclusion Criteria:

  • Current pregnancy
  • Desire/intent to become pregnant over the course of the study
  • Women who are less than 6 weeks postpartum
  • Contraindications to hormonal contraceptive use per package insert, including history of deep vein thrombosis, smoking in women older than 35 years
  • Current IUD
  • Unable to comprehend consent material because of language barrier or psychological difficulty

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cyclic NuvaRing CVR Use
CVR use for 3 weeks, remove for 1 week, then replace
Drug: NuvaRing
Experimental: Continuous NuvaRing CVR Use
CVR use for 4 weeks, then replace
Drug: NuvaRing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantity of BV-associated bacteria by qPCR and high-throughput sequencing tests
Time Frame: Up to 8 months
Up to 8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quantity of vaginal defensins and cytokines
Time Frame: Up to 8 months
Up to 8 months
Rates of incident BV
Time Frame: Up to 8 months
Up to 8 months
Rates of HSV-2 viral shedding among HSV-2-infected women assessed by PCR
Time Frame: Up to 3 months
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

November 1, 2021

Study Registration Dates

First Submitted

April 24, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

May 4, 2015

Study Record Updates

Last Update Posted (Actual)

November 18, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003584
  • U19AI113173 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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