Outcomes’10 participates in a clinical trial that will evaluate a pioneering treatment for a pathology that affects between 5-10% of women of reproductive age.
- Polycystic Ovary Syndrome (PCOS) can cause increased hair growth, acne, irregular menstrual periods, and fertility problems.
- The study, inside the SPIOMET4HEALTH, part of the Horizon 2020 programme and funded by the European Commission, will be carried out in Spain, Italy, Denmark, Turkey, Austria and Norway.
Outcomes’10 participates in an international clinical trial to evaluate on a large scale the effects of the first specific treatment for Polycystic Ovary Syndrome, 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 condition’s cause, rather than simply alleviating its symptoms, as is currently the case. Ninety-eight percentage of women with the condition are treated with oral contraceptives to control some of the symptoms.
This phase II clinical trial will be conducted in Spain, Italy, Denmark, Turkey, Austria and Norway. It is part of the European SPIOMET4HEALTH project, funded by the European Commission’s H2020 programme.
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.
SPIOMET4HEALTH involves 17 organisations from 9 European countries. Hospitals, research centres, associations and high-profile companies working on PCOS all over Europe.
It 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 can 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. The trial is being conducted in 7 different centres in 4 European member states and 2 associated countries, such as Università di Bologna in Bologna (Italy), Odense Universitets Hospital in Odense (Denmark), Istanbul University in Istanbul (Turkey), MEdizinische Universitat Graz in Graz (Austria), Norwegian University of Science and Technology in Trondheim (Norway), them the Sant Joan de Déu Hospital in Barcelona and the Institute for Biomedical Research of Girona Dr. Josep Trueta (Spain) and the recruitment period extends until April 2024.
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. Seventy 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.
To be part of the clinical trial, people interested in taking part in the clinical trial can contact the research staff via the website SPIOMET4HEALTH or send an e-mail to: info@spiomet4health.eu.
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 899671.
