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

Primary Purpose

Bacterial Vaginosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
NuvaRing
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacterial Vaginosis focused on measuring HSV-2, Contraceptive Vaginal Ring

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts 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

Sites / Locations

  • UW Virology Research Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cyclic NuvaRing CVR Use

Continuous NuvaRing CVR Use

Arm Description

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

CVR use for 4 weeks, then replace

Outcomes

Primary Outcome Measures

Quantity of BV-associated bacteria by qPCR and high-throughput sequencing tests

Secondary Outcome Measures

Quantity of vaginal defensins and cytokines
Rates of incident BV
Rates of HSV-2 viral shedding among HSV-2-infected women assessed by PCR

Full Information

First Posted
April 24, 2015
Last Updated
November 16, 2021
Sponsor
University of Washington
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT02432404
Brief Title
Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity
Official Title
Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
November 2021 (Actual)
Study Completion Date
November 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
Keywords
HSV-2, Contraceptive Vaginal Ring

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyclic NuvaRing CVR Use
Arm Type
Active Comparator
Arm Description
CVR use for 3 weeks, remove for 1 week, then replace
Arm Title
Continuous NuvaRing CVR Use
Arm Type
Experimental
Arm Description
CVR use for 4 weeks, then replace
Intervention Type
Drug
Intervention Name(s)
NuvaRing
Primary Outcome Measure Information:
Title
Quantity of BV-associated bacteria by qPCR and high-throughput sequencing tests
Time Frame
Up to 8 months
Secondary Outcome Measure Information:
Title
Quantity of vaginal defensins and cytokines
Time Frame
Up to 8 months
Title
Rates of incident BV
Time Frame
Up to 8 months
Title
Rates of HSV-2 viral shedding among HSV-2-infected women assessed by PCR
Time Frame
Up to 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Johnston, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
UW Virology Research Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15339769
Citation
Veres S, Miller L, Burington B. A comparison between the vaginal ring and oral contraceptives. Obstet Gynecol. 2004 Sep;104(3):555-63. doi: 10.1097/01.AOG.0000136082.59644.13.
Results Reference
background
PubMed Identifier
18614873
Citation
Atashili J, Poole C, Ndumbe PM, Adimora AA, Smith JS. Bacterial vaginosis and HIV acquisition: a meta-analysis of published studies. AIDS. 2008 Jul 31;22(12):1493-501. doi: 10.1097/QAD.0b013e3283021a37.
Results Reference
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PubMed Identifier
22745608
Citation
Cohen CR, Lingappa JR, Baeten JM, Ngayo MO, Spiegel CA, Hong T, Donnell D, Celum C, Kapiga S, Delany S, Bukusi EA. Bacterial vaginosis associated with increased risk of female-to-male HIV-1 transmission: a prospective cohort analysis among African couples. PLoS Med. 2012;9(6):e1001251. doi: 10.1371/journal.pmed.1001251. Epub 2012 Jun 26.
Results Reference
background
PubMed Identifier
21975269
Citation
Heffron R, Donnell D, Rees H, Celum C, Mugo N, Were E, de Bruyn G, Nakku-Joloba E, Ngure K, Kiarie J, Coombs RW, Baeten JM; Partners in Prevention HSV/HIV Transmission Study Team. Use of hormonal contraceptives and risk of HIV-1 transmission: a prospective cohort study. Lancet Infect Dis. 2012 Jan;12(1):19-26. doi: 10.1016/S1473-3099(11)70247-X. Epub 2011 Oct 3. Erratum In: Lancet Infect Dis. 2012 Feb;12(2):98.
Results Reference
background
PubMed Identifier
24023807
Citation
Vodstrcil LA, Hocking JS, Law M, Walker S, Tabrizi SN, Fairley CK, Bradshaw CS. Hormonal contraception is associated with a reduced risk of bacterial vaginosis: a systematic review and meta-analysis. PLoS One. 2013 Sep 4;8(9):e73055. doi: 10.1371/journal.pone.0073055. eCollection 2013.
Results Reference
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Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity

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