SJD Barcelona Children's Hospital leads a worldwide clinical trial on polycystic ovarian syndrome (PCOS)
PCOS affects 5-10% of women of reproductive age and can cause increased body hair, acne, irregular menstrual periods and fertility problems.
SJD Barcelona Children's Hospital is leading SPIOMET4HEALTH, a large-scale international clinical trial currently being launched to test the effects of the first specific treatment for polycystic ovarian syndrome (PCOS), a disorder that affects 5-10% of women of reproductive age. This syndrome can cause increased body hair and acne, irregular menstrual periods and fertility problems.
Despite being the most common endocrine disorder in women of reproductive age, awareness of it is very low amongst the general population. It can also lead to the development of other diseases such as type 2 diabetes, cancer before menopause and anxiety or depression, greatly affecting quality of life.
The clinical trial is aiming to treat the cause of this disorder for the first time, rather than just relieving the symptoms, as happens now. In fact, 98% of women affected by this disorder are treated with oral contraceptives to control some of the symptoms. The trial, which will be carried out in Spain (Barcelona and Girona), Italy, Denmark, Turkey, Austria and Norway, will test a treatment for adolescents and young women affected by PCOS that tackles the root cause of the syndrome. Participants will take one tablet a day containing a low-dose combination of three drugs that have been on the market for twenty years or more (spironolactone, pioglitazone and metformin), which, along with a healthy lifestyle, could normalise hormone levels and ovulation and so reverse the changes associated with PCOS.
SPIOMET4HEALTH is funded by the European Commission and brings together a consortium of 17 key organisations and research groups working on polycystic ovarian syndrome across Europe. It will be coordinated by a research team from the Sant Joan de Déu Research Institute, led by Dr Lourdes Ibáñez, winner of the National Research Prize of Catalonia in 2014 and recently honoured by two top-level international institutions, the American Endocrine Society and the American Human Growth Foundation.
This project is extremely important because, if the effectiveness of the medication is confirmed, for the first time it will be possible to permanently reverse the complications associated with polycystic ovarian syndrome, such as infertility, diabetes and low self-esteem.
Criteria for taking part in the clinical trial
Women diagnosed with polycystic ovarian syndrome may take part in this clinical trial if they are between the ages of 12 and 24, have irregular periods, excess body hair and/or persistent and severe acne. The trial will be conducted in Catalonia, both in Barcelona (SJD Barcelona Children's Hospital) and in Girona (Dr. Josep Trueta Girona Biomedical Research Institute).
The treatment will last one year, and the patient will be followed up for another 6 months, in order to confirm the changes that occur during and after taking the medication. We hope to recruit a total of 70 patients in Barcelona and 46 in Girona. The results will serve as the basis for a phase III clinical trial, which will enable this novel approach to be used throughout Europe. Subsequent introduction of the treatment should help save between 500 million and 1 billion euros per year for the healthcare system.
For more information, visit the SPIOMET4HEALTH clinical trial website.