Overview

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