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

Phase 4

Completed

• Conditions: Bacterial Vaginosis
• Interventions: Drug: NuvaRing

• Registration Number: NCT02432404
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-24
• Study First Submitted QC: 2015-04-28
• Study First Posted: 2015-05-04
• Study Start: 2016-03
• Primary Completion: 2021-11
• Study Completion: 2021-11
• Results First Submitted: 2023-04-17
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Results First Posted: 2025-02-05
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous NuvaRing CVR Use	NuvaRing	CVR use for 4 weeks, then replace
Cyclic NuvaRing CVR Use	NuvaRing	CVR use for 3 weeks, remove for 1 week, then replace

Primary Outcome Measures

Name	Time	Method
Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests	Up to 8 months	Change in Log10 quantity of bacteria detected (L. crisptatus, L. jensenii, L. iners, G. vaginalis, Megasphaera spp. BVAB2)

Secondary Outcome Measures

Name	Time	Method
Number of Visits With BV	Up to 8 months	Number of visits with BV prior to use of NuvaRing CVR compared to during NuvaRing CVR use.

Trial Locations

Locations (1)

UW Virology Research Clinic; 🇺🇸 Seattle, Washington, United States