Objective PCOS, a common disorder affecting 5-10% of women of reproductive age is characterized by cystic ovarian morphology, androgen excess, and/or irregular periods and emerges during or shortly after puberty. The common off-label use of metformin for treating PCOS in children appears to have no greater risk than that in adults; drug tolerance is good with limited adverse effects. However, clinical trials are needed and requested by EMA to validate the safety and efficacy of this agent in PCOS.In January 2012, the EMA released a revised priority list of PUMA generic medicines and Metformin was identified as a requested drug for treatment of PCOS in children. The call requests data on pharmacokinetics, efficacy and safety in this indication. A PIP was submitted to EMA in August 2012. In its final opinion of 17 May 2013 the PDCO recommend to agree to the PIP. The PDCO and the consortium have agreed that by restricting exposure to no more than 2000 mg metformin / day, no additional pharmacokinetic investigations are required or even requested by EMA.METFIZZ will conduct the required product development and clinical studies to establish efficacy and safety of administering age-appropriate innovative effervescent soluble formulations of metformin. The studies will focus attention on ethics in this psychologically sensitive condition, guided by the current legislation and by engaging patients and caregivers along with an independent ethics expert.Currently, there are no age-appropriate dosing forms of metformin for treatment of PCOS in paediatric populations. This can result in over or under dosing, lack of medication compliance, dangers of iatrogenic harms. METFIZZ embraces clinical development, manufacturing scale up, and registration aspects of this pharmaceutical development programme.Coordinator SME EffRx together with 4 SME-CROs and at least 20-30 related study centres will carry out the clinical study in 4 EU member states. The statistical analysis plan requires approximately 150 patients to be randomized into the PCOS study. EffRx will lead the METFIZZ product commercialisation to benefit children in Europe. Fields of science medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsmedical and health sciencesbasic medicinepharmacology and pharmacypharmacokinetics Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Topic(s) HEALTH.2013.4.2-1 - Investigator-driven clinical trials for off-patent medicines using innovative, age-appropriate formulations and/or delivery systems Call for proposal FP7-HEALTH-2013-INNOVATION-1 See other projects for this call Funding Scheme CP-FP - Small or medium-scale focused research project Coordinator EFFRX PHARMACEUTICALS SA EU contribution € 1 839 700,00 Address WOLLERAUSTRASSE 41 B 8807 FREIENBACH Switzerland See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Ana Johansson (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data Participants (6) Sort alphabetically Sort by EU Contribution Expand all Collapse all KLIFO AS Denmark EU contribution € 1 681 637,00 Address FRUEBJERGVEJ 3 2100 KOBENHAVN See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Alejandra Moerk (Ms.) Links Contact the organisation Opens in new window Total cost No data Campbell Charles Associates (2000) Ltd United Kingdom EU contribution € 1 486 921,00 Address Station Road 48 KT11 3BN STOKE D ABERNON See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Ignazio Di Giovanna (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data SERMES PLANIFICACION Spain EU contribution € 366 229,00 Address CALLE RUFINO GONZALEZ 14 28037 MADRID See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Antonio Berlanga (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data RCTS - RANDOMIZED CLINICAL TRIALS France EU contribution € 398 875,00 Address RUE DU PLAT 38 69002 LYON See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Yves Alamercery (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data SCIPROM SARL Switzerland EU contribution € 177 000,00 Address RUE DU CENTRE 70 1025 Saint Sulpice See on map Region Schweiz/Suisse/Svizzera Région lémanique Vaud Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Kirsten Leufgen (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data THE UNIVERSITY OF LIVERPOOL United Kingdom EU contribution € 49 600,00 Address BROWNLOW HILL 765 FOUNDATION BUILDING L69 7ZX Liverpool See on map Region North West (England) Merseyside Liverpool Activity type Higher or Secondary Education Establishments Administrative Contact Jenny Lawson (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data