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: January 4, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 21, 2011

Last Updated Date

January 4, 2012

Start Date ^ICMJE

June 2011

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Changes in vaginal, cervical and uterine bacterial species with levonorgestrel intrauterine device placement [ Time Frame: May 2012 ] [ 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

Change History

Complete list of historical versions of study NCT01496898 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Inflammatory cytokine changes with levonorgestrel intrauterine device placement [ Time Frame: May 2012 ] [ 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.

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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:

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.
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.
Establish a tissue bank of vaginal, cervical and uterine specimens for future research.

Detailed Description

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Ecologic or Community
Time Perspective: Prospective

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 ^ICMJE

Human Microbiome
Metagenome
Contraception
Cytokine

Intervention ^ICMJE

Study Group/Cohort (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

May 2012

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01496898

Other Study ID Numbers ^ICMJE

uufpf 43416

Has Data Monitoring Committee

Yes

Responsible Party

Janet Jacobson, University of Utah

Study Sponsor ^ICMJE

University of Utah

Collaborators ^ICMJE

Bayer

Investigators ^ICMJE

Principal Investigator:

Janet C Jacobson, MD

University of Utah

Information Provided By

University of Utah

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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