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

Descrizione del progetto

Valutazione di un trattamento innovativo della sindrome dell’ovaio policistico in pazienti giovani

La sindrome dell’ovaio policistico, la causa più frequente di infertilità anovulatoria, colpisce una percentuale significativa di adolescenti e giovani donne in tutto il mondo. In un panorama in cui mancano terapie efficaci, studi pilota hanno portato allo sviluppo di un nuovo farmaco focalizzato sulla reversione del fenotipo di sindrome dell’ovaio policistico senza effetti collaterali attraverso una singola compressa chiamata SPIOMET. Il progetto SPIOMET4HEALTH, finanziato dall’UE, si propone di valutare questo approccio innovativo concentrandosi sugli effetti additivi dei componenti di SPIOMET. Il progetto aspira a fornire la prima prova su larga scala sui benefici psicosociali dei trattamenti testati e a contribuire a un solido processo decisionale sulla sindrome dell’ovaio policistico nei sistemi sanitari europei.

Obiettivo

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.

Invito a presentare proposte

H2020-SC1-BHC-2018-2020

Vedi altri progetti per questo bando

Bando secondario

H2020-SC1-2020-Two-Stage-RTD

Meccanismo di finanziamento

RIA - Research and Innovation action

Coordinatore

FUNDACIO PRIVADA PER A LA RECERCA I LA DOCENCIA SANT JOAN DE DEU
Contribution nette de l'UE
€ 1 333 865,00
Indirizzo
SANTA ROSA 39-4
08950 Esplugues De Llobregat
Spagna

Mostra sulla mappa

Regione
Este Cataluña Barcelona
Tipo di attività
Research Organisations
Collegamenti
Costo totale
€ 1 715 031,25

Partecipanti (19)