Phase 4
N=81
Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity
Bacterial Vaginosis
Bottom Line
View on ClinicalTrials.gov: NCT02432404 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests — 5.59; 5.22; 4.91; 7.41 log10 copies/ml — p=0.011
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- NuvaRing (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Washington
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests |
5.59; 5.22; 4.91; 7.41; 7.49; 7.89 | 0.011 sig |
| SECONDARY Number of Visits With BV |
15; 6; 4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02432404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.