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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Human Microbiome Metagenome Contraception Cytokine

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes