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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Janet Jacobson, University of Utah
ClinicalTrials.gov Identifier:
NCT01496898
First received: August 21, 2011
Last updated: June 7, 2013
Last verified: June 2013

August 21, 2011
June 7, 2013
June 2011
December 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Characterization of vaginal, cervical and uterine bacterial species and communities prior to and after LNG IUD placement using bacterial DNA microarray analysis
Changes in vaginal, cervical and uterine bacterial species with levonorgestrel intrauterine device placement [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
Characterization of vaginal, cervical and uterine bacterial species and communities prior to and after LNG IUD placement using bacterial DNA microarray analysis
Complete list of historical versions of study NCT01496898 on ClinicalTrials.gov Archive Site
Inflammatory cytokine changes with levonorgestrel intrauterine device placement [ Time Frame: 1 day prior to IUD insertion to 3 weeks after IUD insertion ] [ Designated as safety issue: No ]
Characterization of vaginal, cervical and uterine inflammatory cytokine milieu prior to and after LNG IUD placement using human RNA microarray analysis.
Inflammatory cytokine changes with levonorgestrel intrauterine device placement [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
Characterization of vaginal, cervical and uterine inflammatory cytokine milieu prior to and after LNG IUD placement using human RNA microarray analysis.
Not Provided
Not Provided
 
Changes in Vaginal, Cervical and Uterine Microflora With Levonorgestrel Intrauterine Device Placement
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.
Not Provided
Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

A total of 648 samples will be collected from 12 participants for bacterial species and human cytokine analysis in 9 collection visits. Specimens will be collected up to one week prior to IUD insertion and two months after IUD insertion. Vaginal and cervical specimens will be collected using FLOQSwabs® (Copan) to maximize bacterial DNA sample collection. Uterine samples will be collected by uterine irrigation with sterile saline using an embryo replacement catheter.

Non-Probability Sample

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

  • Human Microbiome
  • Metagenome
  • Contraception
  • Cytokine
Not Provided
Not Provided
Jacobson JC, Turok DK, Dermish AI, Nygaard IE, Settles ML. Vaginal microbiome changes with levonorgestrel intrauterine system placement. Contraception. 2014 Aug;90(2):130-5. doi: 10.1016/j.contraception.2014.04.006. Epub 2014 Apr 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
13
July 2013
December 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01496898
uufpf 43416
Yes
Janet Jacobson, University of Utah
University of Utah
Bayer
Principal Investigator: Janet C Jacobson, MD University of Utah
University of Utah
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP