Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 55 of 126 for:    HSV-2

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02432404
Recruitment Status : Active, not recruiting
First Posted : May 4, 2015
Last Update Posted : January 31, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Christine Johnston, University of Washington

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
Bacterial Vaginosis Drug: NuvaRing Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : March 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

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



Primary Outcome Measures :
  1. Quantity of BV-associated bacteria by qPCR and high-throughput sequencing tests [ Time Frame: Up to 8 months ]

Secondary Outcome Measures :
  1. Quantity of vaginal defensins and cytokines [ Time Frame: Up to 8 months ]
  2. Rates of incident BV [ Time Frame: Up to 8 months ]
  3. Rates of HSV-2 viral shedding among HSV-2-infected women assessed by PCR [ Time Frame: Up to 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432404


Locations
Layout table for location information
United States, Washington
UW Virology Research Clinic
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Layout table for investigator information
Principal Investigator: Christine Johnston, MD, MPH University of Washington

Publications:
Layout table for additonal information
Responsible Party: Christine Johnston, Assistant Professor, Medicine/Division of Allergy and Infectious Diseases, University of Washington
ClinicalTrials.gov Identifier: NCT02432404     History of Changes
Other Study ID Numbers: STUDY00003584
U19AI113173 ( U.S. NIH Grant/Contract )
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

Layout table for additional information
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, University of Washington:
HSV-2
Contraceptive Vaginal Ring
Additional relevant MeSH terms:
Layout table for MeSH terms
Vaginosis, Bacterial
Vaginal Diseases
Genital Diseases, Female
Bacterial Infections
Vaginitis
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs