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

2 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

120

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Kenia
      • Thika, Kenia
        • Partners in Health and Research Development
        • Contacto:
          • Prof. Nelly R. Mugo
          • Número de teléfono: +254723914057
          • Correo electrónico: rwamba@uw.edu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.
Dispositivo: Copper T Intrauterine device (Cu-IUD)
Product will be used as labeled for approximately 12 months.
Otros nombres:
  • Model TCu 380A, manufactured by the SMB Corporation of India or by Bayer Pharmaceuticals
Comparador activo: 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
Droga: Levonorgesterel Intrauterine system (LNG IUS)
Product will be used as labeled for approximately 12 months.
Otros nombres:
  • Mirena®, manufactured by Bayer Healthcare
  • Avibela, manufactured by DKT WomenGloba

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cross-sectional comparisons of vaginal microbial Shannon alpha diversity.
Periodo de tiempo: 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)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Comparisons of host epithelial integrity factors via metaproteomics
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Seattle Children's Hospital

Colaboradores

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

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de julio de 2029

Finalización del estudio (Estimado)

1 de julio de 2030

Fechas de registro del estudio

Enviado por primera vez

29 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de junio de 2026

Publicado por primera vez (Actual)

4 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de junio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • STUDY00005850
  • R01HD118913 (Subvención/contrato del NIH de EE. UU.)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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