Clinical Trials Directory

Trials / Completed

CompletedNCT01496898

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

Vaginal Microflora and Inflammatory Markers Before and After Levonorgestrel Device Insertion

Status
Completed
Phase
Study type
Observational
Enrollment
13 (actual)
Sponsor
University of Utah · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2011-01-01
Primary completion
2011-12-01
Completion
2013-07-01
First posted
2011-12-21
Last updated
2016-01-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01496898. Inclusion in this directory is not an endorsement.