SPIOMET4HEALTH
Financiado
PCOS IN ADOLESCENT GIRLS AND YOUNG WOMEN TOWARD A TREATMENT GUIDED BY PATHOPHYS...
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. Ther...
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.
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Duración del proyecto: 61 meses
Fecha Inicio: 2021-02-01
Fecha Fin: 2026-03-31
Fecha Fin: 2026-03-31
Línea de financiación: concedida
El organismo H2020 notifico la concesión del proyecto el día 2021-02-01
Línea de financiación objetivo
El proyecto se financió a través de la siguiente ayuda:
SC1-BHC-08-2020:
New interventions for Non-Communicable Diseases
Cerrada
hace 5 años
Presupuesto
El presupuesto total del proyecto asciende a
6M€
Líder del proyecto
FUNDACIO PRIVADA PER LA RECERCA I LA DOCENCIA...
Otras actividades asociativas n.c.o.p. asociacion
Perfil tecnológico
TRL
4-5
50K
Perfil tecnológico
TRL
4-5
50K
249.49K€ |
Participante