An interventional study of Levonorgesterel Intrauterine system (LNG IUS) and Copper T Intrauterine device (Cu-IUD) in Vaginal Microbial Diversity, sponsored by Seattle Children's Hospital. Not yet recruiting at 1 site in Kenya. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Supportive care
Among 17 studies in Sexually Transmitted Diseases with a site in Kenya — 4 open to participants now, 6 under way, none of them phase 3. Sexually Transmitted Diseases · Kenya.
Among the 17 studies in Sexually Transmitted Diseases with a site in Kenya, this one is the 14th largest by planned enrollment of the 16 interventional ones that give a count, is one of 2 that started in 2026, is one of 7 with no phase, and was the 16th registered.
523 studies on the registry are indexed under Sexually Transmitted Diseases; 77 are open to participants now.
Browse Sexually Transmitted Diseases studies →4 of the 17 studies in Sexually Transmitted Diseases with a site in Kenya are open now. Recruiting first, the newest first:
University of California, San Francisco · Sites in Kenya
Ages 15+ · Healthy volunteers
University of Washington · Sites in Kenya
Women only · Healthy volunteers
Henry M. Jackson Foundation for the Advancement of Military Medicine · Sites in Kenya, Nigeria, Philippines and 1 more country
Ages 14–55
A study can be open while its sites in Kenya have not opened yet or have stopped. Only those recruiting at a site in Kenya →
Of the 47 Sexually Transmitted Diseases studies recruiting now, 29 (62%) set no upper age limit and 16 (34%) stop at 75 or younger; 22 take children under 18; 33 take healthy volunteers.
This study: 18 Years to 40 Years · female · healthy volunteers too.
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17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 3 · Phase 4 3
First in 2002; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 120 is below the median of 449 across 425 interventional studies indexed under Sexually Transmitted Diseases.
Median enrollment 665 across the 16 interventional studies, 2,500 across the 1 observational. Of the 10 that completed or were terminated, 2 (20%) have results posted.
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1 of 17 have an industry lead sponsor. The 10 most frequent:
Seattle Children's Hospital is the lead sponsor of 215 studies on the registry; 44 are open to participants now.
Seattle Children's Hospital has 2 studies filed under Sexually Transmitted Diseases — fewer than ten, so there is no comparison to draw.
1 of the studies in Sexually Transmitted Diseases with a site in Kenya that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07587281Pacific Institute for Research and EvaluationEvaluation of a Mobile Health Intervention to Improve Sexual and Reproductive Health Outcomes Among Kenyan Adolescents Living in Urban Informal Settlements | 2027-05-31 |
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Among the 17 studies in Sexually Transmitted Diseases with a site in Kenya, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Medical (Category 3 or 4 criteria as detailed in the WHO MEC1 to copper IUDs or LNG-IUS, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Copper T Intrauterine device (Cu-IUD)
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
Drug: Levonorgesterel Intrauterine system (LNG IUS)
Product will be used as labeled for approximately 12 months.
Also known as: Mirena®, manufactured by Bayer Healthcare, Avibela, manufactured by DKT WomenGloba
Product will be used as labeled for approximately 12 months.
Also known as: Model TCu 380A, manufactured by the SMB Corporation of India or by Bayer Pharmaceuticals
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.
Time frame: 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.
Time frame: From enrollment to the end of participation at 12 months
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.
Time frame: From enrollment to the end of participation at 12 months
Start is estimated for Jul 2026; primary completion for Jul 2029, 36 months later.
Of 172 non-industry interventional studies with no phase under Sexually Transmitted Diseases, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 47. This study's planned 36 months is above that.
Counting every sponsor, half of 182 studies reached it within 31 months; a quarter within 16 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Sexually Transmitted Diseases →