Human MicrobiomeNCT01496898
Changes in Vaginal, Cervical and Uterine Microflora With Levonorgestrel Intrauterine Device Placement
An observational study of Human Microbiome and Metagenome, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Microbiome, Metagenome, Contraception
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Caucasian woman aged 18 to 45 seeking intrauterine contraception meeting inclusion criteria.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Hospital
Salt Lake City, Utah, 84132
About this study
Official title: Vaginal Microflora and Inflammatory Markers Before and After Levonorgestrel Device Insertion
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.
- Conditions
- Human Microbiome, Metagenome, Contraception, Cytokine
- Keywords
- Microflora, Vaginal, Cervical, Uterine, Inflammation, Cytokine, Intrauterine Device, Levonorgestrel
- Medical subject headings
- Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week prior to IUD insertion to 2 months after IUD insertion
Secondary outcomes (1)
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.
Measured: 1 day prior to IUD insertion to 3 weeks after IUD insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human MicrobiomeStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Janet C Jacobson, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496898
- Sponsor's protocol ID
- uufpf 43416
- Status last verified
- Jan 2016
- First submitted
- 21 Aug 2011
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jacobson JC, Turok DK, Dermish AI, Nygaard IE, Settles ML. Vaginal microbiome changes with levonorgestrel intrauterine system placement. Contraception. 2014 Aug;90(2):130-5. doi: 10.1016/j.contraception.2014.04.006. Epub 2014 Apr 21.
PubMed 24835828
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Microflora and Inflammatory Markers Before and After Levonorgestrel Device Insertion
- ClinicalTrials.gov ID
- NCT01496898
- Acronym / sponsor ID
- uufpf 43416
- Conditions
- Human Microbiome, Metagenome, Contraception, Cytokine
- Keywords
- Microflora, Vaginal, Cervical, Uterine, Inflammation, Cytokine, Intrauterine Device, Levonorgestrel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 21 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Caucasian woman aged 18 to 45 seeking intrauterine contraception meeting inclusion criteria.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Uterine Abnormalities
- Current use of hormonal contraceptives or use less than 3 months ago
- Unexplained vaginal bleeding
- Irregular menses
- Cervical dysplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Characterization of vaginal, cervical and uterine bacterial species and communities prior to and after LNG IUD placement using bacterial DNA microarray analysis
1 secondary outcome
Inflammatory cytokine changes with levonorgestrel intrauterine device placement
Time frame: 1 day prior to IUD insertion to 3 weeks after IUD insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Derived from this study: PubMed 24835828Jacobson JC, Turok DK, Dermish AI, Nygaard IE, Settles ML. Vaginal microbiome changes with levonorgestrel intrauterine system placement. Contraception. 2014 Aug;90(2):130-5. doi: 10.1016/j.contraception.2014.04.006. Epub 2014 Apr 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet C Jacobson, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Microbiome and Metagenome, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01496898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.