Title {1}	SPIOMET4HEALTH – Efficacy, Tolerability and Safety of a Fixed Dose Combination of Spironolactone, Pioglitazone & Metformin (SPIOMET) plus Lifestyle Intervention for Adolescent Girls and Young Women with Polycystic Ovary Syndrome: Study Protocol for a Multicentre, Randomised, Double-Blind, Placebo-Controlled, Four-Arm Parallel Groups Clinical Trial
Trial registration {2a and 2b}	EudraCT: 2021–003177-58
Protocol version {3}	Version 4.0; 15 November 2022
Funding {4}	The SPIOMET4HEALTH project received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 899671. The funding body had no role in the design of the study, in the collection, analysis and interpretation of data and in writing the manuscript
Author details {5a}	1Paediatric Endocrinology, Paediatric Research Institute Sant Joan de Déu, University of Barcelona, 08950 Esplugues, Barcelona, Spain 2Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), ISCIII, 28029 Madrid, Spain 3Department of Gynaecology and Obstetrics and Department of Endocrinology, University of Southern Denmark, Odense University Hospital, Odense, Denmark 4Pediatric Endocrinology Unit, Istanbul University, Istanbul, Turkey 5Maternal-Fetal Metabolic Research Group, Girona Institute for Biomedical Research (IDIBGI), Girona, Spain 6Department of Paediatric Endocrinology, Diabetes and Nutrition Medicine, Vestische Hospital for Children and Adolescents Datteln, University of Witten-Herdecke, Datteln, Germany 7Department of Medical and Surgical Science-DIMEC, Division of Endocrinology and Diabetes Prevention and Care, University of Bologna—S. Orsola-Hospital, Bologna, Italy 8Division of General Paediatrics, Department of Paediatrics and Adolescent Medicine, Medical University of Graz, Graz, Austria 9Paediatric Endocrinology Research Group, Girona Institute for Biomedical Research (IDIBGI); Paediatrics, Dr. Josep Trueta Hospital; and Department of Medical Sciences, University of Girona, Girona, Spain 10Asphalion, Barcelona, Spain 11Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria 12Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway 13Centre for Obesity Research, St. Olavs Hospital, Trondheim University Hospital, Torgarden, Trondheim, Norway 14Department of Radiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy 15Department of Obstetrics and Gynaecology, St. Olavs Hospital, Trondheim University Hospital, 7006 Trondheim, Norway 16Optimapharm, Palma de Mallorca, Spain 17Leuven Research & Development, University of Leuven, 3000 Leuven, Belgium
Name and contact information for the trial sponsor {5b}	Fundació de Recerca Sant Joan de Déu Carrer de Santa Rosa 39–57 08950 Esplugues de Llobregat, Barcelona Spain
Role of sponsor {5c}	The funding instance has no role in the study design, data collection, data analysis and interpretation, writing the report or decision to submit the report for publication. The Sponsor will act as recruiting partner and as the coordinator of the clinical trial