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

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ClinicalTrials.gov Identifier: NCT01496898
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : January 13, 2016
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
University of Utah

Tracking Information
First Submitted Date August 21, 2011
First Posted Date December 21, 2011
Last Update Posted Date January 13, 2016
Study Start Date January 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 4, 2012)
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
Original Primary Outcome Measures
 (submitted: December 15, 2011)
Changes in vaginal, cervical and uterine bacterial species with levonorgestrel intrauterine device placement [ Time Frame: May 2012 ]
Characterization of vaginal, cervical and uterine bacterial species and communities prior to and after LNG IUD placement using bacterial DNA microarray analysis
Change History Complete list of historical versions of study NCT01496898 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 4, 2012)
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.
Original Secondary Outcome Measures
 (submitted: December 15, 2011)
Inflammatory cytokine changes with levonorgestrel intrauterine device placement [ Time Frame: May 2012 ]
Characterization of vaginal, cervical and uterine inflammatory cytokine milieu prior to and after LNG IUD placement using human RNA microarray analysis.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Changes in Vaginal, Cervical and Uterine Microflora With Levonorgestrel Intrauterine Device Placement
Official Title Vaginal Microflora and Inflammatory Markers Before and After Levonorgestrel Device Insertion
Brief Summary

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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen 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.
Sampling Method Non-Probability Sample
Study Population Caucasian woman aged 18 to 45 seeking intrauterine contraception meeting inclusion criteria.
Condition
  • Human Microbiome
  • Metagenome
  • Contraception
  • Cytokine
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 15, 2011)
13
Original Actual Enrollment Same as current
Actual Study Completion Date July 2013
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01496898
Other Study ID Numbers uufpf 43416
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Utah
Study Sponsor University of Utah
Collaborators Bayer
Investigators
Principal Investigator: Janet C Jacobson, MD University of Utah
PRS Account University of Utah
Verification Date January 2016