
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.
This project aims to develop and implement a circular economy approach for sustainable products and services through their value and supply chains. Three new circular economy business models will be developed including (i) co-creation of products and services, (ii) sustainable consumption, and (iii) collaborative recycling and reuse. The Co-creation of Products/Services model will bring end-users closer to the design and manufacturing phases by identifying consumer preferences via Big-data online mining product reviews and evaluating product specifications and prototypes via Living Lab to customise the end-user requirements. Benefited from the co-creation features, sets of sustainable production methods will be implemented and new products/services will be created. The Sustainable Consumption model will develop a method to calculate the eco-points of products based on the outcome of FP7 myEcoCost project, assess product environment footprints (PEF), provide a traceability solution to monitor product’s sustainability along the value chain, and support end-users and stakeholders to actively implement the circular economy via awareness raising and knowledge sharing activities. The Collaborative Recycling/Reuse model will develop a system for stakeholders to interact with each other to facilitate the use/reuse of end-of-life products and reduce waste, and implement the eco-credits awarding scheme to encourage people to recycle/reuse. This project will be demonstrated at a large scale in electrical and electronic products and farming/agri-foods sectors, provide an effective means to communicate with wide communities to disseminate the project outcome, and involve a large number of stakeholders along value and supply chains throughout the project lifetime, including end-users, producers, researchers and civil society. An ICT platform will be developed to support the development, implementation, demonstration, communication and dissemination.