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PAPIONRandomized, Placebo-controlled, Double-blind Study to Evaluate 2LPAPI® Efficacy on the Clearance of Genital HR-HPV Infections.

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

2LPAPI®

+ Placebo

Medicamento
Quiénes están siendo reclutados

De 25 a 45 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Controlado con PlaceboFase 4
Intervencional
Inicio del estudio: octubre de 2020
Ver detalles del protocolo

Resumen

Patrocinador PrincipalLabo'Life
Contacto del EstudioLaura FERTEMás contactos
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 17 de octubre de 2020

Fecha en la que se inscribió al primer participante.

The study duration will be 72 months with 60 months of inclusion (that may be extended if the expected number of patients is not reached after 60 months) and 12 months of follow-up. Patients aged between 25 and 45 years presenting a diagnosis of HR-HPV infection during the routine screening visit for cervical cancer prevention. The total number of patients to include will be 284 with 142 patients per group. Primary objective: Comparison of the efficacy of 2LPAPI® versus placebo on the clearance of genital HR-HPV infections after 12 months of follow-up. Secondary objectives: Comparison of 2LPAPI® versus placebo on: * HR-HPV infection clearance rate at 6-month visits, * HR-HPV infection clearance rate by HPV type at 6-month and 12-month visits, * Evolution of cytology, * Normalization of cytology for the subpopulation of patients with a baseline non normal cytology, * Safety: adverse events (AEs) and serious adverse events (SAEs), considered as related or not to the study drug. Treatment phase: Group n°1 = 2LPAPI® (6 months of treatment) Group n°2 = Placebo (6 months of treatment) Post-treatment follow-up phase: 6 months. Treatment will be considered successful if the clearance of HR-HPV is done and the cytology is normal.

Título OficialRandomized, Placebo-controlled, Double-blind Study to Evaluate 2LPAPI® Efficacy on the Clearance of Genital HR-HPV Infections.
NCT04232917
Patrocinador PrincipalLabo'Life
Contacto del EstudioLaura FERTEMás contactos
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 284 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Criterios

Mujer

Sexo biológico de los participantes elegibles para inscribirse.

De 25 a 45 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Criterios

Inclusion Criteria: * Women 25-45 years, * Women of childbearing age under effective contraception, * Patient with last cytology less than 3 years and normal or not more than LSIL or CIN I at the histology, * Patient with current cytology presenting normal, ASC-US, AGUS, LSIL, ASC-H, AGC or LSIL+ASC-H results or current diagnosis of CIN I at the histology, * Patient with HR-HPV diagnosis at the current cervical collection, * Patient reporting a current stable sexual relationship (steady sexual partner during study duration), * Patient having faculties to understand and respect the constraints of the study, * Signature of the Informed Consent Form. Exclusion Criteria: * Pregnant or breastfeeding woman, * Patient presenting HSIL diagnosis at the cytology or CIN II or CIN III diagnosis at the histology, * Patient having received HPV vaccination in the last month, * Patient previously subject to total hysterectomy, * Patient under immunotherapy (including immunosuppressive treatment) or micro-immunotherapy received during last previous 6 months, * Patient with known lactose intolerance, * Patient who participated in a clinical study in the previous 3-months' period, * Patient who is not sufficiently motivated to engage in a follow-up period of 12 months, or likely to travel or to move before the end of the study, * Patient with severe immunodeficiency disease requiring long term treatment (\*) or under chemotherapy or radiotherapy, * Patient under listed homeopathic or phytotherapy treatment (see protocol), * Patient using or addicted to recreational drugs. (\*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

50% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.

Grupo II

Placebo
The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 12 ubicaciones

Reclutando

UCL Namur - site Sainte Elisabeth

Namur, BelgiumAbrir UCL Namur - site Sainte Elisabeth en Google Maps
Reclutando

CHWAPI

Tournai, Belgium
Reclutando

CHU Saint-Pierre

Brussels, Belgium
Reclutando

Clinique St Jean

Brussels, Belgium
Reclutando
12 Centros de Estudio