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PCOS IN ADOLESCENT GIRLS AND YOUNG WOMEN: TOWARD A TREATMENT GUIDED BY PATHOPHYSIOLOGY

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.

Call for proposal

H2020-SC1-2020-Two-Stage-RTD
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Funding Scheme

RIA - Research and Innovation action

Coordinator

FUNDACIO SANT JOAN DE DEU
Address
Calle Santa Rosa, 39-57
08950 Esplugues De Llobregat
Spain
Activity type
Research Organisations
EU contribution
€ 1 720 031,25

Participants (16)

KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
EU contribution
€ 249 486,25
Address
Oude Markt 13
3000 Leuven
Activity type
Higher or Secondary Education Establishments
FUNDACIO INSTITUT D'INVESTIGACIO BIOMEDICA DE GIRONA DOCTOR JOSEP TRUETA
Spain
EU contribution
€ 231 535
Address
Calle Dr. Castany Sn Edificio De La Mancomunidad 2 Parque Hospitalario Marti Julia
17190 Girona
Activity type
Research Organisations
Private Universitaet Witten/Herdecke gGmbH
Germany
EU contribution
€ 110 687,50
Address
Alfred-herrhaussen Strasse 50
58455 Witten
Activity type
Higher or Secondary Education Establishments
MEDIZINISCHE UNIVERSITAT GRAZ
Austria
EU contribution
€ 587 476,25
Address
Auenbruggerplatz 2
8036 Graz
Activity type
Higher or Secondary Education Establishments
REGION SYDDANMARK
Denmark
EU contribution
€ 367 426,25
Address
Damhaven 12
7100 Vejle
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
NORGES TEKNISK-NATURVITENSKAPELIGE UNIVERSITET NTNU
Norway
EU contribution
€ 320 037,25
Address
Hogskoleringen 1
7491 Trondheim
Activity type
Higher or Secondary Education Establishments
ALMA MATER STUDIORUM - UNIVERSITA DI BOLOGNA
Italy
EU contribution
€ 397 820
Address
Via Zamboni 33
40126 Bologna
Activity type
Higher or Secondary Education Establishments
ISTANBUL UNIVERSITESI
Turkey
EU contribution
€ 261 262,50
Address
Istanbul Universitesi Center Campus Beyazit Eminonu
34452 Istanbul
Activity type
Higher or Secondary Education Establishments
SYNTAX FOR SCIENCE SL
Spain
EU contribution
€ 769 031,25
Address
Ctra De Valldemossa Km 7'4 Parc Bit Edificio Disset
07121 Palma De Mallorca
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
LABORATORIO REIG JOFRE SA
Spain
EU contribution
€ 507 855
Address
Calle Gran Capita 10
08970 Sant Joan Despi
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSIDAD COMPLUTENSE DE MADRID
Spain
EU contribution
€ 103 125
Address
Avenida De Seneca 2
28040 Madrid
Activity type
Higher or Secondary Education Establishments
OUTCOMES'10 SL
Spain
EU contribution
€ 121 250
Address
Avda Vicent Sos Banyat (Campus Riu Sec) S/n Parc Cientific Tecnologic (Uji)
12006 Castellón De La Plana
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EUROPEAN INSTITUTE OF WOMEN'S HEALTH COMPANY LIMITED BY GUARANTEE
Ireland
EU contribution
€ 93 125
Address
Pearse Street 33
2 Dublin
Activity type
Research Organisations
MAKE MOTHERS MATTER EU DELEGATION
Belgium
EU contribution
€ 93 125
Address
Rue De La Gare 36
1040 Bruxelles
Activity type
Other
ASPHALION SL
Spain
EU contribution
€ 223 125
Address
Calle Tarragona, Numeros 151-157, Planta 10, Bloqu
08014 Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
IN-COGNITA COMINUCACIO CIENTIFICA SCP
Spain
EU contribution
€ 209 750
Address
Calle Maspons 22 1 2A
08012 Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)