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Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function Among Young African Women

2 juni 2026 bijgewerkt door: Heather Jaspan, Seattle Children's Hospital

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:

  1. Whether women assigned to copper IUD vs hormonal IUS have differences in vaginal microbial diversity after 1 year of use
  2. Whether women randomized to Copper IUD have reduced genital mucosal barrier integrity as indicated by proteomic signatures
  3. 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

120

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Kenia
      • Thika, Kenia
        • Partners in Health and Research Development
        • Contact:
          • Prof. Nelly R. Mugo
          • Telefoonnummer: +254723914057
          • E-mail: rwamba@uw.edu

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • 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
  • Sexually active
  • HIV-negative
  • Would benefit from STI prevention

Exclusion Criteria:

  • 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
  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Copper T-380 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.
Apparaat: Copper T Intrauterine device (Cu-IUD)
Product will be used as labeled for approximately 12 months.
Andere namen:
  • Model TCu 380A, manufactured by the SMB Corporation of India or by Bayer Pharmaceuticals
Actieve vergelijker: Levonorgestrel 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
Geneesmiddel: Levonorgesterel Intrauterine system (LNG IUS)
Product will be used as labeled for approximately 12 months.
Andere namen:
  • Mirena®, manufactured by Bayer Healthcare
  • Avibela, manufactured by DKT WomenGloba

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cross-sectional comparisons of vaginal microbial Shannon alpha diversity.
Tijdsspanne: 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.
From enrollment to the end of participation at 12 months
Cross-sectional comparisons of Bray-Curtis distances (Beta diversity)
Tijdsspanne: 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.
From enrollment to the end of participation at 12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Comparisons of host epithelial integrity factors via metaproteomics
Tijdsspanne: From enrollment to the end of participation at 12 months
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.
From enrollment to the end of participation at 12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Seattle Children's Hospital

Medewerkers

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Onderzoekers

  • Hoofdonderzoeker: Heather Jaspan, MD, PhD, Seattle Children's Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 juli 2029

Studie voltooiing (Geschat)

1 juli 2030

Studieregistratiedata

Eerst ingediend

29 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juni 2026

Eerst geplaatst (Werkelijk)

4 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juni 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY00005850
  • R01HD118913 (Subsidie/contract van de Amerikaanse NIH)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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