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

Contraception Clinical Trial

Official title:

Vaginal Microflora and Inflammatory Markers Before and After Levonorgestrel Device Insertion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496898
• Other study ID #: uufpf 43416
• Status: Completed
• Phase: N/A
• First received: August 21, 2011
• Last updated: January 11, 2016
• Start date: January 2011
• Est. completion date: July 2013

Study information

• Verified date: January 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraception
• Cytokine
• Human Microbiome
• Metagenome

Locations

Country	Name	City	State
United States	University of Utah Hospital	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in vaginal, cervical and uterine bacterial species with levonorgestrel intrauterine device placement	Characterization of vaginal, cervical and uterine bacterial species and communities prior to and after LNG IUD placement using bacterial DNA microarray analysis	1 week prior to IUD insertion to 2 months after IUD insertion	No
Secondary	Inflammatory cytokine changes with levonorgestrel intrauterine device placement	Characterization of vaginal, cervical and uterine inflammatory cytokine milieu prior to and after LNG IUD placement using human RNA microarray analysis.	1 day prior to IUD insertion to 3 weeks after IUD insertion	No