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EU funding (€6,366,149): PCOS IN ADOLESCENT GIRLS AND YOUNG WOMEN: TOWARD A TREATMENT GUIDED BY PATHOPHYSIOLOGY Hor 5 Feb 2021 EU Research and Innovation programme "Horizon"
Overview
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PCOS IN ADOLESCENT GIRLS AND YOUNG WOMEN: TOWARD A TREATMENT GUIDED BY PATHOPHYSIOLOGY
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.
Funded Companies:
| Company name | Funding amount |
| Alma Mater Studiorum - Universita Di Bologna | €288,533 |
| Asphalion SL | €223,125 |
| European Institute of Women's Health CLG | €93,125 |
| Fundacio Institut D'Investigacio Biomedica de Girona Doctor Josep Trueta | €197,158 |
| Fundacio Privada Per A La Recerca i La Docencia Sant Joan de Deu | €1,883,212 |
| Hospital Sant Joan de Deu | €0.00 |
| IN-Cognita Cominucacio Cientifica SCP | €2,140.91 |
| Irccs Azienda Ospedaliero- Universitaria Di Bologna | €0.00 |
| Istanbul Universitesi | €253,499 |
| Katholieke Universiteit Leuven | €249,486 |
| Laboratorio Reig Jofre SA | €503,886 |
| Make Mothers Matter EU Delegation | €93,125 |
| Medizinische Universitat Graz | €426,079 |
| Norges Teknisk-Naturvitenskapelige Universitet Ntnu | €368,142 |
| Optimapharm Contract Research Organisation SL | €939,275 |
| Outcomes'10 SL | €121,250 |
| Private Universitaet Witten/Herdecke gGmbH | €110,688 |
| Region Syddanmark | €302,691 |
| Universidad Complutense de Madrid | €103,125 |
| Zabala Innovation Consulting SA | €207,609 |
Source: https://cordis.europa.eu/project/id/899671
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