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PCOS IN ADOLESCENT GIRLS AND YOUNG WOMEN: TOWARD A TREATMENT GUIDED BY PATHOPHYSIOLOGY

Descripción del proyecto

DE EN ES FR IT PL

Evaluación de un tratamiento innovador para el síndrome del ovario poliquístico en pacientes jóvenes

El síndrome del ovario poliquístico (SOPQ) constituye la causa más frecuente de subfertilidad de causa anovulatoria y afecta a una parte importante de las jóvenes y adolescentes de todo el mundo. Ante la falta de tratamientos eficaces, una serie de estudios piloto ha dado lugar al desarrollo de un nuevo medicamento centrado en la reversión del fenotipo SOPQ sin efectos secundarios mediante un comprimido único llamado SPIOMET. El proyecto financiado con fondos europeos SPIOMET4HEALTH tiene por objeto evaluar este método innovador centrándose en los efectos aditivos de los componentes de SPIOMET. El proyecto aspira a proporcionar los primeros datos a gran escala sobre los beneficios psicosociales de los tratamientos evaluados y contribuir a una toma de decisiones sólida sobre el SOPQ en los sistemas de salud europeos.

Objetivo

Polycystic Ovary Syndrome (PCOS) is the most prevalent, chronic endocrine-metabolic disorder of adolescents and young women (AYAs), affecting 5-10% of AYAs worldwide. It is the most frequent cause of anovulatory subfertility. There is no approved therapy for PCOS. Standard off-label treatment with oral contraceptives reverts neither the underlying pathophysiology nor the associated co-morbidities
Pilot studies have generated new insights into the pathophysiology of PCOS, and have thus led to the development of a new approach wherein the PCOS phenotype is reverted without side effects. The novel medication is a fixed, low-dose combination of two insulin sensitisers [Pioglitazone (Pio), Metformin (Met)] and one mixed anti-androgen and anti-mineralocorticoid (Spironolactone (Spi)] within a single tablet: SPIOMET
SPIOMET4HEALTH will test, in a multicentre Phase II trial, the additive effects of each SPIOMET component, on top of lifestyle measures in AYAs with PCOS. SPIOMET aims at normalising the ovulation rate and endocrine-metabolic status via the reduction of hepato-visceral fat excess, in an early phase of the disorder. This approach is expected to reduce the risk of morbidity (including subsequent anovulatory subfertility), to improve the quality of life, and to lower the economic burden on European healthcare systems.
The consortium clusters the experts from key research groups working on PCOS in AYAs, across Europe. The design of SPIOMET4HEALTH foresees that the patients themselves will be engaged over the entire timespan of the project, and will also contribute to the ultimate study evaluation. The update and validation of PCOS-specific Patient Reported Outcome Measures (PROM) will provide the first large-scale evidence on the psychosocial benefits of the tested treatments.
The collective evidence from SPIOMET4HEALTH, once completed with economic modelling, will lead to conclusions that inform sound decision-making about PCOS across European healthcare systems.

Ámbito científico

Palabras clave

Programa(s)

Tema(s)

Convocatoria de propuestas

H2020-SC1-BHC-2018-2020

Consulte otros proyectos de esta convocatoria

Convocatoria de subcontratación

H2020-SC1-2020-Two-Stage-RTD

Régimen de financiación

RIA - Research and Innovation action

Coordinador

FUNDACIO PRIVADA PER A LA RECERCA I LA DOCENCIA SANT JOAN DE DEU
Aportación neta de la UEn
€ 1 333 865,00
Dirección
SANTA ROSA 39-4
08950 Esplugues De Llobregat
España

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Región
Este Cataluña Barcelona
Tipo de actividad
Research Organisations
Enlaces
Coste total
€ 1 715 031,25

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Última actualización: 7 Mayo 2024

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Permalink: https://cordis.europa.eu/project/id/899671/es

European Union, 2024