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.