Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

2. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Enhed: Copper T Intrauterine device (Cu-IUD)
Product will be used as labeled for approximately 12 months.
Andre navne:
  • Model TCu 380A, manufactured by the SMB Corporation of India or by Bayer Pharmaceuticals
Aktiv komparator: 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
Medicin: Levonorgesterel Intrauterine system (LNG IUS)
Product will be used as labeled for approximately 12 months.
Andre navne:
  • Mirena®, manufactured by Bayer Healthcare
  • Avibela, manufactured by DKT WomenGloba

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cross-sectional comparisons of vaginal microbial Shannon alpha diversity.
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparisons of host epithelial integrity factors via metaproteomics
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Seattle Children's Hospital

Samarbejdspartnere

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

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2029

Studieafslutning (Anslået)

1. juli 2030

Datoer for studieregistrering

Først indsendt

29. april 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY00005850
  • R01HD118913 (U.S. NIH-bevilling/kontrakt)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner