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OpenTrials
Completed

NCT Number: NCT02432404

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

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.

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Key information

Conditions

Bacterial Vaginosis Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

UW Virology Research Clinic

Seattle, Washington, 98104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NuvaRing

Drug

Primary outcomes

  1. Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests

    Time frame: Up to 8 months

    Change in Log10 quantity of bacteria detected (L. crisptatus, L. jensenii, L. iners, G. vaginalis, Megasphaera spp. BVAB2)

Secondary outcomes

  1. Number of Visits With BV

    Time frame: Up to 8 months

    Number of visits with BV prior to use of NuvaRing CVR compared to during NuvaRing CVR use.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
May 4, 2015
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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