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

Información del proyecto

SPIOMET4HEALTH

Identificador del acuerdo de subvención: 899671

DOI 10.3030/899671

Fecha de la firma de la CE 1 Febrero 2021

Fecha de inicio 1 Abril 2021

Fecha de finalización 31 Marzo 2026

Financiado con arreglo a

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Coste total € 6 366 148,50

Aportación de la UE € 6 366 148,50

Coordinado por

FUNDACIO PRIVADA PER A LA RECERCA I LA DOCENCIA SANT JOAN DE DEU
Spain

Resultado final

Documents, reports (2)

First study subject approval package

Will include:--- Templates of the Informed Consent Document (in language and terms intelligible to the participants), and details on how the consent of the legal representatives (and assent, when applicable) will be acquired-- Approvals required for invitation / enrolment of first subject in at least one clinical centre: ethics committees, national competent authorities and copies of opinion or confirmation by the competent Institutional Data Protection Officer (DPO) and/or authorization or notification by the National Data Protection Authority-- Registration number of clinical study in a WHO- or ICMJE- approved registry that also allows later posting of study results:-- Final version of study protocol as approved by first regulator / ethics committee(s), including: The procedures to be adopted to ensure the sensitive management of the participation of vulnerable individuals must be described and submitted as a deliverable; Details on incidental findings policy; The measures that will be adopted, at the end of the trial, with regard to the individuals to whom the placebo has not been administered.-- A document enclosing details on the type of cells and tissues from biobanks used in the project, as well as biobanks details (including but not limited to access restrictions). A paragraph has been added to section 5.1.4 Human Cells and TissuesM12

Report on communication and dissemination activities

A detailed list of dissemination activities carried out halfway through the project, with assessment of their impact, the degree of compliance with the plan, and a description of foreseen dissemination activities until the end of the project.Update 1 - month 24Update 2 - month 36Update 3 - month 48Update 4 - month 60

Websites, patent fillings, videos etc. (1)

Project Website

A specific website for the project as described in task 6.3 will be developed. A document including screenshots and the link to the website will be generated.

Publicaciones

Peer reviewed articles (2)

study protocol for a multicentre, randomised, double-blind, placebo-controlled, four-arm, parallel-group, phase II clinical trial

Autores: Garcia-Beltran, Cristina; Malpique, Rita; Andersen, Marianne S.; Bas, Firdevs; Bassols, Judit; Darendeliler, Feyza; Díaz, Marta; Dieris, Barbara; Fanelli, Flaminia; Fröhlich-Reiterer, Elke; Gambineri, Alessandra; Glintborg, Dorte; López-Bermejo, Abel; Mann, Christopher; Marin, Silvia; Obermayer-Pietsch, Barbara; Ødegård, Rønnaug; Ravn, Pernille; Reinehr, Thomas; Renzulli, Matteo; Salvado
Publicado en: Crossref, Edición 4, 2023, ISSN 1539-3704
Editor: PubMed
DOI: 10.1186/s13063-023-07593-6

ODP426 SPIOMET4HEALTH: a 4-Arm Trial to Test the Effects of Lifestyle Intervention plus either Placebo, or Pioglitazone (PIO), or Spironolactone-Pioglitazone (SPIO), or Spironolactone-Pioglitazone-Metformin (SPIOMET) in Adolescent Girls and Young Women with PCOS

Autores: Lourdes Ibanez; Francis de Zegher; Rita Malpique; Firdevs Bas; Feyza Darendeliler; Flaminia Fanelli; Alessandra Gambineri; Judit Bassols; Abel Lopez-Bermejo; Barbara Obermayer-Pietsch; Veronika Tandl; Dorte Glintborg; Pernille Ravn; Barbara Dieris; Viola Singer; Thomas Reinehr; Ronnaug Odegard; Eszter Vanky
Publicado en: Crossref, Edición 7, 2022, ISSN 2472-1972
Editor: Jorunal of the Endocrine Society
DOI: 10.1210/jendso/bvac150.1382