With patient recruitment and the clinical intervention completed, the SPIOMET4HEALTH consortium is now focusing on data analysis and on assessing the feasibility of a new treatment that could mark a milestone in the clinical and metabolic management of polycystic ovary syndrome (PCOS) in adolescents and young women.
Polycystic ovary syndrome (PCOS) is one of the most common endocrine–metabolic disorders in adolescents and young women, affecting approximately ten percent of this population. Its manifestations —including menstrual irregularities, excess body hair, acne and impaired fertility— can have a significant impact on long-term health and quality of life. Despite its high prevalence and clinical relevance, there is currently no specific treatment for PCOS, forcing healthcare professionals and patients to rely on therapies that address individual symptoms rather than the underlying causes of the condition.
In this context, SPIOMET4HEALTH is working towards the development of the first treatment specifically designed for PCOS. The project, which has been underway since 2021, aims to generate robust scientific evidence that could transform the future management of this condition and improve patients’ long-term quality of life. To this end, a new therapeutic combination has been designed and evaluated through a clinical trial conducted in six countries (Spain, Austria, Norway, Italy, Denmark, and Turkey). Combined with an appropriate lifestyle intervention, this therapy seeks to restore endocrine–metabolic function in young women with PCOS.
With the project scheduled to conclude in December 2026, SPIOMET4HEALTH now enters its final year having consolidated key milestones and with a clearly defined, results-oriented work plan.
Clinical progress, European cooperation, and solid scientific evidence
Throughout 2025, SPIOMET4HEALTH achieved key advances that have enabled the project to move into its final phase. Participant recruitment was completed across all clinical trial sites, and more than 80% of the enrolled young women have already completed their assigned treatment or intervention. The clinical trial involved 312 adolescents and young women aged between 12 and 24 years diagnosed with PCOS. All participants received close medical follow-up from the project’s healthcare teams, along with lifestyle recommendations to support their wellbeing and the management of the syndrome.
SPIOMET4HEALTH is a phase II clinical trial aiming to develop a single tablet that combines three medicines —spironolactone (SPI), pioglitazone (PIO) and metformin (MET)— which have already demonstrated benefits in the management of PCOS in pilot studies. To identify the safest and most effective formulation, the trial compares different combinations and doses of these three medicines with a placebo group.
Following completion of the intervention phase, the consortium has been able to collect the essential clinical data and advance preliminary analyses and data quality validation, a crucial step to ensure the robustness of the study.
As explained by the project coordinator, Dr Lourdes Ibáñez, from Hospital Sant Joan de Déu in Barcelona:
“SPIOMET4HEALTH is now entering a crucial period. Thanks to the commitment of the consortium and the young women who participated, we are closer to obtaining solid evidence on a potential new therapeutic pathway for PCOS. This project represents an exceptional European effort to improve the future health of millions of women.”
2026 to-dos: final results and next regulatory steps
SPIOMET4HEALTH begins 2026 with a defined work plan and a well-established operational structure. The study databases are closed or in the final stages of monitoring and validation, a key process prior to the start of the final analyses. Collaboration among the scientific teams at the participating centres enables coordinated preparation for the next phase of the project: a comprehensive evaluation of the effects and safety of the investigated treatment.
During this final year, the consortium will focus on completing the efficacy and safety analyses that will determine the therapeutic potential of the evaluated combination. In parallel, assessments of the clinical, scientific and regulatory feasibility of the treatment will be carried out, together with the preparation of the final reports for the European Commission.
The project will also continue advancing its results exploitation strategies and regulatory preparation, while maintaining strong communication and knowledge-transfer activities aimed at healthcare professionals, the scientific community and society at large.
