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

Information source: University of Utah
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Human Microbiome; Metagenome; Contraception; Cytokine

Phase: N/A

Status: Active, not recruiting

Sponsored by: University of Utah

Official(s) and/or principal investigator(s):
Janet C Jacobson, MD, Principal Investigator, Affiliation: University of Utah

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.

Clinical Details

Official title: Vaginal Microflora and Inflammatory Markers Before and After Levonorgestrel Device Insertion

Study design: Observational Model: Ecologic or Community, Time Perspective: Prospective

Primary outcome: Changes in vaginal, cervical and uterine bacterial species with levonorgestrel intrauterine device placement

Secondary outcome: Inflammatory cytokine changes with levonorgestrel intrauterine device placement

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

University of Utah Hospital, Salt Lake City, Utah 84132, United States
Additional Information

Starting date: June 2011
Last updated: June 7, 2013

Page last updated: August 23, 2015

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