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6 M€

Total budget




Polycystic Ovary Syndrome (PCOS) is the most prevalent, chronic, endocrine-metabolic disorder in women of reproductive age, affecting 5-10% of women worldwide. It is the most frequent cause of anovulatory subfertility, and it is also associated with lifelong co-morbidities such as type 2 diabetes, premature vascular aging, premenopausal cancer and anxiety or depression.

There is currently no approved treatment for PCOS in adolescent and young women, approximately 98% of whom are prescribed oral contraceptives (OCs) off-label. OCs do alleviate key symptoms, such hirsutism and menstrual irregularity, but do not revert the underlying pathophysiology, and patients remain at risk for post-treatment subfertility.


Previous studies by FSJD and Katholieke Universiteit Leuven have led to the identification of a treatment, (SPIOMET) that consists of two “insulin sensitisers” (pioglitazone [PIO] and metformin [MET]) and a mixed anti-androgen and anti-mineralocorticoid (spironolactone [SPI]), which also acts as a brown adipose tissue activator. However, these studies had some limitations that SPIOMET4HEALTH aims to overcome. The project will test a novel treatment of SPIOMET in a single tablet (SPI, 50 mg; PIO, 7.5 mg and MET, 850 mg) administered daily, in combination with certain lifestyle measures. It aims at normalising ovulation and endocrine-metabolic status through reduction of hepato-visceral fat excess.


SPIOMET4Health could change the current paradigm of PCOS treatment, as the new therapy will not only target the gonadotropic axis, but also the underlying pathophysiology. This strategy should also reduce the psychosocial impact and economic burden of PCOS on healthcare systems. SPIOMET4HEALTH can also become a preconception strategy to be followed by spontaneous ovulation/conception, normal pregnancy and a healthier next generation.

This project has received funding from the European Union’s Horizon 2020 research and innovation programme, under grant agreement No. 899671.

Laura Sesma

“SPIOMET4Health is proposed by a consortium of the highest-profile groups working on PCOS in adolescent girls and young adults (AYAs); this project offers the EU a unique opportunity to enable a robust attempt to generate medical benefits for patients with PCOS.”

Laura Sesma

Team leader expert in European Programmes in the Health Area

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