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
  Purpose

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.

Condition
Human Microbiome
Metagenome
Contraception
Cytokine

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Vaginal Microflora and Inflammatory Markers Before and After Levonorgestrel Device Insertion

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

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.


Enrollment: 13
Study Start Date: June 2011
Estimated Study Completion Date: July 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496898

Locations
United States, Utah
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Bayer
Investigators
Principal Investigator: Janet C Jacobson, MD University of Utah
  More Information

No publications provided by University of Utah

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janet Jacobson, Family Planning Fellow, Department of Obstetrics and Gynecology, University of Utah
ClinicalTrials.gov Identifier: NCT01496898     History of Changes
Other Study ID Numbers: uufpf 43416
Study First Received: August 21, 2011
Last Updated: June 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Microflora
Vaginal
Cervical
Uterine
Inflammation
Cytokine
Intrauterine Device
Levonorgestrel

Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on August 21, 2014