The study will soon start in Italy, Denmark, Turkey, Austria and Norway too
We are conducting an international clinical trial now underway in Spain to evaluate on a large scale the effects of the first specific treatment for Polycystic Ovary Syndrome (PCOS), a condition that affects between 5 and 10% of women of reproductive age. This syndrome can cause increased body hair and acne, irregular menstrual periods, and fertility problems.
PCOS is the most common endocrine disorder in women of reproductive age, but, at the same time, it is one of the most unknown pathologies among 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, which has an impact on the quality of life of these women.
The clinical trial is aimed for the first time at treating the cause, rather than simply alleviating its symptoms, as is currently the case. In fact, 98% of women with the condition are treated with oral contraceptives to control some of the symptoms. It consists of evaluating a treatment for adolescents and young women affected by Polycystic Ovary Syndrome that addresses the root of the syndrome. It is a daily tablet, which is a low-dose combination of three drugs that have been on the market for two or more decades (spironolactone, pioglitazone and metformin), which, together with a healthy lifestyle, could normalise hormones and ovulation, and thus reverse the alterations associated with PCOS. It is classified as phase II and will be conducted in Spain, Italy, Denmark, Turkey, Austria and Norway.
SPIOMET4HEALTH involves 17 organisations from 9 European countries. Hospitals, research centres, associations and high-profile companies working on PCOS all over Europe.
The project is coordinated by a research team from the Institut de Recerca Sant Joan de Déu (Barcelona, Spain), led by Dr Lourdes Ibáñez, winner of the Premi Nacional de Recerca de Catalunya in 2014 and recently awarded by two leading international institutions, such as the American Endocrine Society and the American Human Growth Foundation.
Lourdes Ibáñez said: “This project is very important because, if the effectiveness of the medication is confirmed, for the first time it will permanently reverse the complications associated with Polycystic Ovary Syndrome, such as infertility, diabetes and low self-esteem.”
Criteria for joining the clinical trial
Women diagnosed with Polycystic Ovary Syndrome will be able to participate in this clinical trial if they are between 12 and 24 years old, have irregular menstruation, excess hair growth and/or persistent and severe acne. In Spain, where the trial has already started, it will be carried out in Catalonia, both in Barcelona (Hospital Sant Joan de Déu) and Girona (Institut d’Investigació Biomèdica de Girona Dr. Josep Trueta).
The treatment will be carried out for one year, and the patient will be monitored for a further 6 months to check the changes that occur during and after the medication. A total of 70 patients are expected to be recruited in Barcelona and 46 in Girona. The results will serve as the basis for a phase III clinical trial to exploit this novel approach across Europe; subsequent implementation of the treatment will save the healthcare system between 500 and 1 billion euros per year.
Read more information about the clinical trial (in Spanish) here and be part of the solution!