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

University of Washington

Status and phase: Completed; Phase 4

Conditions: Bacterial Vaginosis

Treatments: Drug: NuvaRing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02432404

U19AI113173 (U.S. NIH Grant/Contract)

STUDY00003584

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

Cyclic NuvaRing CVR Use

Active Comparator group

Description:

CVR use for 3 weeks, remove for 1 week, then replace

Treatment:

Drug: NuvaRing

Continuous NuvaRing CVR Use

Experimental group

Description:

CVR use for 4 weeks, then replace

Treatment:

Drug: NuvaRing