Changes in Vaginal, Cervical and Uterine Microflora With Levonorgestrel Intrauterine Device Placement

January 11, 2016 updated by: University of Utah

Vaginal Microflora and Inflammatory Markers Before and After Levonorgestrel Device Insertion

The goal of this study is to examine changes in the bacterial ecology and inflammatory markers of the female genital tract with levonorgestrel intrauterine device placement.

The specific research objectives of this project include:

  1. Characterization of vaginal, cervical and uterine bacterial species and communities prior to and after LNG IUD placement using bacterial DNA microarray analysis. Samples will be collected up to 1 week before and 2 months after IUD insertion.
  2. Characterization of vaginal, cervical and uterine inflammatory cytokine milieu prior to and after LNG IUD placement using human RNA microarray analysis. Samples will be analyzed from up to one day before and three weeks after IUD insertion.
  3. Establish a tissue bank of vaginal, cervical and uterine specimens for future research.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Caucasian woman aged 18 to 45 seeking intrauterine contraception meeting inclusion criteria.

Description

Inclusion Criteria:

  • Not currently pregnant
  • No use of hormonal birth control for at least three months prior to enrollment
  • Desiring levonorgestrel IUD for birth control
  • Greater than 6 months postpartum
  • Greater than 6 weeks after miscarriage
  • No antibiotic use in the past 6 weeks

Exclusion Criteria:

  • Uterine Abnormalities
  • Current use of hormonal contraceptives or use less than 3 months ago
  • Unexplained vaginal bleeding
  • Irregular menses
  • Cervical dysplasia
  • Cervical or vaginal infection in the last 6 weeks
  • Douching within the week prior to sample collection
  • Use of vaginal lubricants within the week prior to sample collection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in vaginal, cervical and uterine bacterial species with levonorgestrel intrauterine device placement
Time Frame: 1 week prior to IUD insertion to 2 months after IUD insertion
Characterization of vaginal, cervical and uterine bacterial species and communities prior to and after LNG IUD placement using bacterial DNA microarray analysis
1 week prior to IUD insertion to 2 months after IUD insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory cytokine changes with levonorgestrel intrauterine device placement
Time Frame: 1 day prior to IUD insertion to 3 weeks after IUD insertion
Characterization of vaginal, cervical and uterine inflammatory cytokine milieu prior to and after LNG IUD placement using human RNA microarray analysis.
1 day prior to IUD insertion to 3 weeks after IUD insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Bayer

Investigators

  • Principal Investigator: Janet C Jacobson, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

August 21, 2011

First Submitted That Met QC Criteria

December 15, 2011

First Posted (Estimate)

December 21, 2011

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 11, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • uufpf 43416

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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