Changes in Vaginal, Cervical and Uterine Microflora With Levonorgestrel Intrauterine Device Place… (NCT01496898) | Clinical Trial Compass
CompletedNot Applicable
Changes in Vaginal, Cervical and Uterine Microflora With Levonorgestrel Intrauterine Device Placement
United States13 participantsStarted 2011-01
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in vaginal, cervical and uterine bacterial species with levonorgestrel intrauterine device placement
Timeframe: 1 week prior to IUD insertion to 2 months after IUD insertion