Clincosm LogoSign in Get a demo

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

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT02432404
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
120
Enrollment
1
Location
2
Arms
68
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity
Actual Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Nov 1, 2021
Actual Study Completion Date :
Nov 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cyclic NuvaRing CVR Use

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

Drug: NuvaRing
Experimental: Continuous NuvaRing CVR Use

CVR use for 4 weeks, then replace

Drug: NuvaRing

Outcome Measures

Primary Outcome Measures

  1. Quantity of BV-associated bacteria by qPCR and high-throughput sequencing tests [Up to 8 months]

Secondary Outcome Measures

  1. Quantity of vaginal defensins and cytokines [Up to 8 months]

  2. Rates of incident BV [Up to 8 months]

  3. Rates of HSV-2 viral shedding among HSV-2-infected women assessed by PCR [Up to 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UW Virology Research Clinic Seattle Washington United States 98104

Sponsors and Collaborators

  • University of Washington
  • National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Christine Johnston, MD, MPH, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Christine Johnston, Assistant Professor, Medicine/Division of Allergy and Infectious Diseases, University of Washington
ClinicalTrials.gov Identifier:
NCT02432404
Other Study ID Numbers:
  • STUDY00003584
  • U19AI113173
First Posted:
May 4, 2015
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Christine Johnston, Assistant Professor, Medicine/Division of Allergy and Infectious Diseases, University of Washington
HSV-2
Contraceptive Vaginal Ring
Additional relevant MeSH terms:
Vaginosis, Bacterial
NuvaRing

Study Results

No Results Posted as of Nov 18, 2021