Status:
COMPLETED
Changes in Vaginal, Cervical and Uterine Microflora With Levonorgestrel Intrauterine Device Placement
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Bayer
Conditions:
Human Microbiome
Metagenome
Eligibility:
FEMALE
18-45 years
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 obj...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01496898
Start Date
January 1 2011
End Date
July 1 2013
Last Update
January 13 2016
Active Locations (1)
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1
University of Utah Hospital
Salt Lake City, Utah, United States, 84132