SPIOMET4HEALTH is a project that aims to provide a novel treatment for adolescent girls and young adult women with Polycystic Ovary Syndrome (PCOS). PCOS negatively affects the health and quality of life of approximately 110 million women who suffer from this syndrome, as well as of their offspring. PCOS has an impact on the emotional, physical, social functioning and behaviour, and on family-related activities.
Women with PCOS usually have infrequent menstrual periods and excessive levels of male hormones (androgens), which are usually present in women in small amounts. Those affected by the syndrome can also suffer from hirsutism, acne and abnormal body fat distribution, which in turn, tends to decrease self-confidence and self-esteem. Consequently, approximately 40% of women with PCOS are known to experience depression or anxiety. In addition, PCOS is often associated with subfertility, which reinforces the dissatisfaction derived from the other symptoms.
PCOS not only has repercussions on the patient, but it also incurs a cost on society: it is estimated that it has a global annual cost of approximately €23 billion in the European health sector.
The new solution that SPIOMET4HEALTH proposes will be tested in Phase II clinical trial in different centres including Spain, Austria, Norway, Italy, Demark and Turkey. SPIOMET4HEALTH is a project funded by the European Union’s Horizon 2020 research and innovation programme.
We are looking for, adolescent girls and young adult women aged 12 to 24 years presently, who suffer from PCOS, to participate in the clinical trial, to test whether our new therapeutic approach holds the potential to improve the health-related quality of life of millions of women with PCOS.
PILOT EVIDENCE BEFORE SPIOMET4HEALTH
Previous pilot studies developed by Fundació Sant Joan de Déu / Hospital Sant Joan de Déu and the Katholieke Universiteit Leuven, identified a new treatment for Polycystic Ovary Syndrome (PCOS), based on the combination of three medications used separately (SPIronolactone (SPI), PIOglitazone (PIO) and METformin (MET): SPIOMET)
However, those studies had some limitations. First, the medications had to be administered separately in three different tablets, with potential compliance problems. In addition, the pilot studies were conducted in small populations with limited ethnic variability. The treatment was also given mainly to women without overweight/obesity, which limits the relevance of the results for this population, who constitute approximately 50% of the PCOS patients.
WHAT SPIOMET4HEALTH WILL DO
SPIOMET4HEALTH will test a new treatment for PCOS: SPIOMET in a single tablet (SPI, 50 mg + PIO, 7.5 mg + MET, 850 mg) administered daily, together with specific lifestyle measures.
This treatment aims to normalise ovulation and endocrine-metabolic status.
SPIOMET4HEALTH offers a pathophysiological approach, since the new therapy will focus not only on the gonadotropic axis but will also impinge on the underlying mechanisms responsible for the development of PCOS.
This new treatment may become a preconception strategy that will likely be followed by spontaneous ovulation or conception, normal pregnancies, and a healthier next generation.
The results of SPIOMET4Health will serve as a basis for a Phase III clinical trial that will enable the exploitation of this novel approach throughout Europe.