Project description
Assessing an innovative treatment of PCOS in young patients
As the most frequent cause of anovulatory subfertility, polycystic ovary syndrome (PCOS) affects a significant percentage of adolescents and young women worldwide. In a landscape that lacks effective therapies, pilot studies have led to the development of a novel medication focused on the reversion of the PCOS phenotype without side effects through a single tablet called SPIOMET. The EU-funded SPIOMET4HEALTH project aims at evaluating this innovative approach focusing on the additive effects of SPIOMET's components. The project aspires to provide the first large-scale evidence on the psychosocial benefits of the tested treatments and to contribute to solid decision-making about PCOS across European healthcare systems.
Objective
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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Funding Scheme
RIA - Research and Innovation actionCoordinator
08950 Esplugues De Llobregat
Spain
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Participants (19)
Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
08950 Esplugues De Llobregat
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3000 Leuven
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17190 Girona
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58455 Witten
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8010 Graz
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7100 Vejle
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7491 Trondheim
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40126 Bologna
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
40138 Bologna
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34452 Istanbul
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07121 PALMA DE MALLORCA
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
08970 Sant Joan Despi
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28040 Madrid
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12006 Castellón de la Plana
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A96 N9K0 DUBLIN
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1040 Bruxelles / Brussel
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08014 Barcelona
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
Participation ended
08012 Barcelona
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31192 Mutilva Alta Navarra
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