Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity
Overview
- Phase
- Phase 4
- Intervention
- NuvaRing
- Conditions
- Bacterial Vaginosis
- Sponsor
- University of Washington
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Christine Johnston
Assistant Professor, Medicine/Division of Allergy and Infectious Diseases
University of Washington
Eligibility Criteria
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
Arms & Interventions
Cyclic NuvaRing CVR Use
CVR use for 3 weeks, remove for 1 week, then replace
Intervention: NuvaRing
Continuous NuvaRing CVR Use
CVR use for 4 weeks, then replace
Intervention: NuvaRing
Outcomes
Primary Outcomes
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
- Number of Visits With BV(Up to 8 months)