SPIOMET4HEALTH is conducting a clinical trial to test a treatment for Polycystic Ovary Syndrome (PCOS), the leading cause of fertility problems in women
PCOS is negatively affecting the health and quality of life of approximately 110 million women worldwide in different ways, 5 to 10% of all women worldwide, and even of their offspring, it is the most common hormonal disorder among women of reproductive age.
Women with PCOS may have a range of symptoms such as infrequent or prolonged menstrual periods, and excessive levels of male hormones (androgens); these are usually present in women in small amounts and may result in excessive body hair (hirsutism) and acne and also contribute to abnormal body fat distribution.
PCOS is also associated with lifelong disorders such as type 2 Diabetes, premature vascular ageing, premenopausal cancer and a higher risk of premature birth in pregnancy.
These are symptoms that not only affect physical health but can also affect women’s self-confidence and self-esteem. In fact, approximately 40% of women with PCOS are known to experience depression or anxiety. This emotional impact is also reinforced by the potential subfertility that PCOS can cause.
You can read here some women’s with PCOS experiences.
How much does PCOS cost the European health sector?
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.
However, there is currently no approved treatment for Polycystic Ovary Syndrome (PCOS) in adolescent girls and young women.
That is why the European Union’s Horizon 2020 research and innovation program is funding the SPIOMET4HEALTH project, which aims to provide a new treatment for adolescent and young adult women with polycystic ovary syndrome.
The clinical trial for PCOS
That is why we are looking for adolescent girls and young adult women aged 12 to 24 years who have a diagnosis of PCOS to participate in the Phase II clinical trial in different centers in Europe (Spain, Italy, Denmark, Turkey, Austria and Norway).
The purpose of the clinical trial is to test whether our new therapeutic approach holds the potential to improve the problems associated to PCOS, and thus the health-related quality of life of millions of women with PCOS. Have a look to our FAQ’s.
Is there a treatment for PCOS?
Our goal? To find a new treatment for PCOS: SPIOMET in a single tablet (spironolactone, SPI, 50 mg + pioglitazone, PIO, 7.5 mg + metformin, MET, 850 mg) administered daily, together with specific lifestyle measures aims to normalise ovulation and endocrine-metabolic status.
SPIOMET4HEALTH will also impinge on the underlying mechanisms responsible for the development of PCOS and its results will serve as a basis for a Phase III clinical trial that will enable the exploitation of this novel approach throughout Europe.
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.
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