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
• Status Verified: 2021-11
• Primary Completion: 2021-11
• Study Completion: 2021-11
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

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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

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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

Secondary Outcome Measures

Name	Time	Method
Rates of HSV-2 viral shedding among HSV-2-infected women assessed by PCR	Up to 3 months
Rates of incident BV	Up to 8 months
Quantity of vaginal defensins and cytokines	Up to 8 months

Trial Locations

Locations (1)

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