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

• Status: Active, not recruiting
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Contraceptive Agents; NuvaRing

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