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

University of Washington81 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Bacterial Vaginosis

Interventions

NuvaRingDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UW Virology Research Clinic

Seattle, Washington, United States

Outcomes

Primary Outcomes

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

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

Time frame: Up to 8 months

Secondary Outcomes

Number of Visits With BV

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

Time frame: Up to 8 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.