Clinical trial begins for treatment of polycystic ovary syndrome

Clinical trial begins for treatment of polycystic ovary syndrome
  • Polycystic ovary syndrome is one of the most common endocrine and metabolic disorders in women of reproductive age.
  • Lourdes Ibáñez, leads an international clinical trial that will evaluate a pioneering treatment worldwide for this pathology.
  • The clinical trial is directed for the first time to treat the cause that produces this disorder, instead of limiting itself to relieving its symptoms, as is currently done.

The CIBERDEM researcher of the Sant Joan de Déu Research InstituteHospital Sant Joan de Déu Barcelona, ​​Lourdes Ibáñez, leads an international clinical trial that will evaluate a pioneering treatment worldwide for a pathology that affects between 5-10 percent of women of reproductive age, the polycystic ovary syndromeknown as SOP.

Polycystic ovary syndrome, one of the most unknown pathologies by the general population

It is one of the most frequent endocrine and metabolic disorders in women of reproductive age, but, at the same time, it is one of the most unknown pathologies by the general population.

In addition, it can facilitate the development of other diseases such as type 2 diabetes, cancer before menopause and anxiety or depression, which affects the quality of life of these people. This syndrome can cause increased body hair and acne, irregular menstrual periods, and fertility problems.

The clinical trial is aimed for the first time at treating the cause of this disorder, rather than just relieve your symptoms, as is currently done. In fact, 98 percent of women affected by this disorder are treated with oral contraceptives to control some of the symptoms.

“This project is very important because, if the effectiveness of the medication is confirmed, it will be possible for the first time to permanently reverse the complications associated with polycystic ovary syndrome, such as infertility, diabetes and low self-esteem”, commented Ibáñez.

The clinical trial is called ‘SPIOMET4HEALTH’

The clinical trial, called ‘SPIOMET4HEALTH’, and classified as phase II, will be carried out in Spain (Barcelona and Girona), Italy, Denmark, Turkey, Austria and Norway. It consists of evaluating a treatment for adolescents and young women affected by polycystic ovary syndrome that addresses the root cause of the syndrome.

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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 normalize hormones and ovulation, thus reversing the alterations associated with PCOS.

The treatment will be carried out for one year, and the patient will be monitored for another 6 months, to verify 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 which will allow this novel approach to be exploited throughout Europe; the subsequent implementation of the treatment will allow the health system to save between 500 and 1,000 million euros per year.

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