CompletedPhase 4

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

United States81 participantsStarted 2016-03

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Up to 8 months

Trial details

NCT IDNCT02432404

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11

Results submitted2023-04-17

View on ClinicalTrials.gov More Bacterial Vaginosis trials