Vaginal Microbial DiversityNCT07627958
Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function Among Young African Women
A study testing Levonorgesterel Intrauterine system (LNG IUS) and Copper T Intrauterine device (Cu-IUD) in people with Vaginal Microbial Diversity, run by Seattle Children's Hospital at 1 site in Kenya.
Trial summary
The goal of this clinical trial is to definitively determine whether copper intrauterine device (IUD) or hormonal intrauterine system (IUS) results in greater vaginal microbial diversity after 1 year in women (n= approximately 120) aged 18-40 years, who desire to use a copper IUD or hormonal IUS as contraception, are… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Microbial Diversity
- What is being tested?
- Levonorgesterel Intrauterine system (LNG IUS) and Copper T Intrauterine device (Cu-IUD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteKenya
- Study dates
- Jul 2026to Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to provide written informed consent for screening and trial participation
- Desire and willingness to use either IUD or IUS for contraception for at least one year
- Clear understanding of study randomization and commitment to use the assigned IUD
- Between 18 and 40 years of age (inclusive)
- Willing and able to actively participate in the study for 12 months
- Willing to be tested for HIV
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- Sexually active
- HIV-negative
- Would benefit from STI prevention
Who cannot join
- Living with HIV or HIV screening results that are not definitively negative
- Currently pregnant or planning to become pregnant within the next 12 months
- Documented or known history of infertility or sterilization
- Prior history of ectopic pregnancy
- Use of contraceptive implant, IUD or injectable progestin in the past 3 months
- Use of oral contraceptives in the past 30 days
Show all 18Show fewer
- Planning to use alternative contraception except condoms for the trial duration
- 0-6 weeks postpartum
- Has had a hysterectomy or sterilization
- History of challenges using and IUD/IUS, including frequent expulsion
- Medical contraindications (Category 3 or 4 criteria as detailed in the WHO MEC1 to copper IUDs or LNG-IUS, including:
- Endometrial, ovarian, or cervical cancer
- Unexplained vaginal bleeding between menstrual periods or bleeding after intercourse
- History of pelvic tuberculosis
- Anatomical abnormality of the uterus incompatible with IUD insertion
- A recent septic abortion
- Untreated mucopurulent cervicitis on exam, untreated pelvic inflammatory disease (PID), or untreated known gonorrhoea or chlamydia
- Has any condition (social or medical), which in the opinion of the investigator, would make study participation unsafe or complicate data interpretation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Study PI, Dr. Jaspan, MD, PhD contact
Kenya1 site
Partners in Health and Research Development
Thika
Prof. Nelly R. Mugo, +254723914057, rwamba@uw.edu
About this study
Official title: Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function: a Randomized Trial Among Young African Women
The goal of this clinical trial is to definitively determine whether copper intrauterine device (IUD) or hormonal intrauterine system (IUS) results in greater vaginal microbial diversity after 1 year in women (n= approximately 120) aged 18-40 years, who desire to use a copper IUD or hormonal IUS as contraception, are HIV-negative and could benefit from STI prevention.
The main questions it aims to answer are:
Read more
- Whether women assigned to copper IUD vs hormonal IUS have differences in vaginal microbial diversity after 1 year of use
- Whether women randomized to Copper IUD have reduced genital mucosal barrier integrity as indicated by proteomic signatures
- Whether women randomized to Copper IUD have greater incidence of high-risk HPV or curable STIs (Ct, Ng, Tv)
Participants will be assigned to have either the copper IUD or the hormonal IUS inserted as contraception. After that, they will have blood and vaginal fluids collected every 3 months for one year to look at the bacteria in their vagina, test for sexually transmitted infections, and examine markers of vaginal health.
After enrolment, each participant will be followed for 12 months, and at the end of the trial, the participant can continue to use the IUD/IUS or the study clinician can remove it.
Read the detailed description
Through this protocol, the investigators will recruit and follow a novel cohort of young women in the Thika, Kenya area. Enrolled women (approximately 120 aged 18-40 years who may benefit from STI prevention) will be randomized to use either Cu-IUD or LNG IUS and followed for 1 year. Through periodic genital sampling and metagenomic sequencing of vaginal wall swabs, the study will definitively determine whether Cu-IUD use (relative to levonorgestrel-containing hormonal IUD use) results in greater vaginal microbial diversity after 1 year. In addition, the study will conduct periodic testing for human papilloma virus (HPV), Chlamydia trachomatis (Ct), Neisseria gonorrhea (Ng), and Trichomonas vaginalis (Tv) to determine whether Cu-IUD users experience greater incidence of high-risk HPV or curable STIs. Finally, the study will conduct proteomic analyses to determine whether Cu-IUD users experience reduced integrity in genital mucosal barriers.
- Conditions
- Vaginal Microbial Diversity
- Being tested
- Levonorgesterel Intrauterine system (LNG IUS), Copper T Intrauterine device (Cu-IUD)
- Keywords
- IUD, IUS, intrauterine devices, Copper intrauterine device, Long-acting reversible contraception, contraception, Women, STI prevention, STI
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgesterel Intrauterine system (LNG IUS)Drug
Also called Mirena®, manufactured by Bayer Healthcare, Avibela, manufactured by DKT WomenGloba
Product will be used as labeled for approximately 12 months.
Copper T Intrauterine device (Cu-IUD)Device
Also called Model TCu 380A, manufactured by the SMB Corporation of India or by Bayer Pharmaceuticals
Product will be used as labeled for approximately 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Copper T-380 intrauterine device (Cu-IUD) | Active comparator | The Cu-IUD will be Model TCu 380A used in public sector services in Kiambu County. Each T-shaped plastic frame has 176 mg of copper wire coiled around its vertical arm and a copper collar of 68 mg of copper on each of its transverse arms for a total copper surface area on the device of 380 mm2.
The product will be sterile and will be inserted as described in the package insert. Receives: Device: Copper T Intrauterine device (Cu-IUD) |
| Levonorgestrel intrauterine system (LNG IUS) | Active comparator | The LNG-IUD consists of a T-shaped polyethylene frame with a steroid reservoir containing 52 mg levonorgestrel packaged with a sterile inserter.
The product will be sterile and will be inserted as described in the package insert Receives: Drug: Levonorgesterel Intrauterine system (LNG IUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-sectional comparisons of vaginal microbial Shannon alpha diversity.
Cross-sectional differences at month-12 in Shannon diversity will be compared using Mann-Whitney U.
Measured: From enrollment to the end of participation at 12 months
Cross-sectional comparisons of Bray-Curtis distances (Beta diversity)
Cross-sectional differences at 12 months of Bray-Curtis distances (ß diversity) will be assessed using PERMANOVAs.
Measured: From enrollment to the end of participation at 12 months
Secondary outcomes (1)
Comparisons of host epithelial integrity factors via metaproteomics
Differential abundance of host proteins will be evaluated using the limma package in R, for each arm, adjusting for potential confounders, and functional enrichment analysis conducted using DAVID. Evaluation of proteomic changes using the MEFISTO R package will be used. The mixOmics R package will be used to identify the minimum protein signature most associated with different contraceptives will be evaluated using sparse PLSDA and Data Integration Analysis and Biomarker discovery using Latent cOmponents (DIABLO). Microbial functional changes will be investigated by aggregation of proteins with the same Gene Ontology.
Measured: From enrollment to the end of participation at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal Microbial DiversityStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Heather Jaspan, Seattle Children's Hospital
- Investigators
- Heather Jaspan, MD, PhD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627958
- Sponsor's protocol ID
- STUDY00005850
- Other IDs
- R01HD118913
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function: a Randomized Trial Among Young African Women
- ClinicalTrials.gov ID
- NCT07627958
- Acronym / sponsor ID
- STUDY00005850
- Conditions
- Vaginal Microbial Diversity
- Keywords
- IUD, IUS, intrauterine devices, Copper intrauterine device, Long-acting reversible contraception, contraception, Women, STI prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 4 Jun 2026 (actual)
- 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 clinical trial is to definitively determine whether copper intrauterine device (IUD) or hormonal intrauterine system (IUS) results in greater vaginal microbial diversity after 1 year in women (n= approximately 120) aged 18-40 years, who desire to use a copper IUD or hormonal IUS as contraception, are HIV-negative and could benefit from STI prevention.
The main questions it aims to answer are:
- Whether women assigned to copper IUD vs hormonal IUS have differences in vaginal microbial diversity after 1 year of use
- Whether women randomized to Copper IUD have reduced genital mucosal barrier integrity as indicated by proteomic signatures
- Whether women randomized to Copper IUD have greater incidence of high-risk HPV or curable STIs (Ct, Ng, Tv)
Participants will be assigned to have either the copper IUD or the hormonal IUS inserted as contraception. After that, they will have blood and vaginal fluids collected every 3 months for one year to look at the bacteria in their vagina, test for sexually transmitted infections, and examine markers of vaginal health.
After enrolment, each participant will be followed for 12 months, and at the end of the trial, the participant can continue to use the IUD/IUS or the study clinician can remove it.
Detailed description
Through this protocol, the investigators will recruit and follow a novel cohort of young women in the Thika, Kenya area. Enrolled women (approximately 120 aged 18-40 years who may benefit from STI prevention) will be randomized to use either Cu-IUD or LNG IUS and followed for 1 year. Through periodic genital sampling and metagenomic sequencing of vaginal wall swabs, the study will definitively determine whether Cu-IUD use (relative to levonorgestrel-containing hormonal IUD use) results in greater vaginal microbial diversity after 1 year. In addition, the study will conduct periodic testing for human papilloma virus (HPV), Chlamydia trachomatis (Ct), Neisseria gonorrhea (Ng), and Trichomonas vaginalis (Tv) to determine whether Cu-IUD users experience greater incidence of high-risk HPV or curable STIs. Finally, the study will conduct proteomic analyses to determine whether Cu-IUD users experience reduced integrity in genital mucosal barriers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Copper T-380 intrauterine device (Cu-IUD) | Active comparator | Device: Copper T Intrauterine device (Cu-IUD)The Cu-IUD will be Model TCu 380A used in public sector services in Kiambu County. Each T-shaped plastic frame has 176 mg of copper wire coiled around its vertical arm and a copper collar of 68 mg of copper on each of its transverse arms for a total copper surface area on the device of 380 mm2. The product will be sterile and will be inserted as described in the package insert. |
| Levonorgestrel intrauterine system (LNG IUS) | Active comparator | Drug: Levonorgesterel Intrauterine system (LNG IUS)The LNG-IUD consists of a T-shaped polyethylene frame with a steroid reservoir containing 52 mg levonorgestrel packaged with a sterile inserter. The product will be sterile and will be inserted as described in the package insert |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Willing and able to provide written informed consent for screening and trial participation
- Desire and willingness to use either IUD or IUS for contraception for at least one year
- Clear understanding of study randomization and commitment to use the assigned IUD
- Between 18 and 40 years of age (inclusive)
- Willing and able to actively participate in the study for 12 months
Key exclusion criteria (18 listed)
- Living with HIV or HIV screening results that are not definitively negative
- Currently pregnant or planning to become pregnant within the next 12 months
- Documented or known history of infertility or sterilization
- Prior history of ectopic pregnancy
- Use of contraceptive implant, IUD or injectable progestin in the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levonorgesterel Intrauterine system (LNG IUS)Also: Mirena®, manufactured by Bayer Healthcare, Avibela, manufactured by DKT WomenGlobaProduct will be used as labeled for approximately 12 months. | Drug | Levonorgestrel intrauterine system (LNG IUS) |
| Copper T Intrauterine device (Cu-IUD)Also: Model TCu 380A, manufactured by the SMB Corporation of India or by Bayer PharmaceuticalsProduct will be used as labeled for approximately 12 months. | Device | Copper T-380 intrauterine device (Cu-IUD) |
Primary outcome
Cross-sectional comparisons of vaginal microbial Shannon alpha diversity.
Time frame: From enrollment to the end of participation at 12 months
Cross-sectional differences at month-12 in Shannon diversity will be compared using Mann-Whitney U.
Cross-sectional comparisons of Bray-Curtis distances (Beta diversity)
Time frame: From enrollment to the end of participation at 12 months
Cross-sectional differences at 12 months of Bray-Curtis distances (ß diversity) will be assessed using PERMANOVAs.
1 secondary outcome
Comparisons of host epithelial integrity factors via metaproteomics
Time frame: From enrollment to the end of participation at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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.
Study PI, Dr. Jaspan, MD, PhD contact
Heather Jaspan, MD, PhD principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levonorgesterel Intrauterine system (LNG IUS) and Copper T Intrauterine device (Cu-IUD) in people with Vaginal Microbial Diversity, run by Seattle Children's Hospital at 1 site in Kenya.
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 9 inclusion and 18 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: opening soon, as of the sponsor's last update on 4 Jun 2026. 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 Kenya. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Stueckle, MPH (1-206-884-1254, laura.stueckle@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-sectional comparisons of vaginal microbial Shannon alpha diversity. (time frame: From enrollment to the end of participation at 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2026.