Abstract
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 antimineralocorticoid (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.
Project details
Unibo Team Leader: Alessandra Gambineri
Unibo involved Department/s:
Dipartimento di Scienze Mediche e Chirurgiche
Coordinator:
Fundació Sant Joan De Deu (Fsjd)(Spain)
Other Participants:
Outcomes'10 Sl
(Spain)
Department of Physics, Norwegian, University of Science and Technology (NTNU)
(Norway)
Katholieke Universiteit Leuven
(Belgium)
In-Cognita Cominucacio Cientifica Scp
(Spain)
Mouvement Mondial des Meres - Europe
(Belgium)
Region Syddanmark
(Denmark)
Universität Witten/Herdecke
(Germany)
Universidad Complutense De Madrid
(Spain)
Medizinische Universität Graz
(Austria)
Laboratorio Reig Jofre Sa
(Spain)
Syntax For Science Sl
(Spain)
Fundacio Institut D'Investigacio Biomedica De Girona Doctor Josep Trueta
(Spain)
European Institute Of Women'S Health Limited
(Ireland)
İstanbul Üniversitesi
(Turkey)
Asphalion Sl
(Spain)
ALMA MATER STUDIORUM - Università di Bologna
(Italy)
Total Eu Contribution: Euro (EUR) 6.366.148,50
Project Duration in months: 60
Start Date:
01/04/2021
End Date:
31/03/2026
This project contributes to the achievement of the Sustainable Development Goals of the UN 2030 Agenda.
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 899671