The answer lies in a recent scientific paper authored by the investigators leading the SPIOMET4HEALTH project. This clinical trial, conducted by seven prominent institutions across six European countries, has been specifically designed to reshape PCOS treatment.
The study is set in institutions known for their excellence in healthcare in six different countries: Spain, Austria, Norway, Italy, Demark and Turkey. This multinational approach ensures a comprehensive understanding of PCOS, contributing to more inclusive and effective treatment strategies.
The study carefully includes adolescents and young women aged between 12 and 23. Criteria such as gynaecological age, androgen excess, and menstrual irregularity are defined, allowing for a targeted examination of PCOS cases.
The inside of the clinical trial: how does it work?
SPIOMET stands for a combination of three medications: pioglitazone (PIO), metformin (MET), and spironolactone (SPI). These medications aim to target the root causes of PCOS, providing a more comprehensive and effective treatment. The ongoing phase II clinical trial involves a randomized, double-blind, placebo-controlled study across seven clinical centers in Europe.
But… what does this mean?
The trial enrolls eligible patients, categorizing them into four groups: the group administered a PIO tablet, the group receiving an SPIO (SPI + PIO) tablet, the group prescribed a SPIOMET tablet (SPI + PIO + MET) and the group receiving a placebo. Over 12 months, participants receive lifestyle guidance alongside a daily tablet at dinner. Following this period, a 6-month post-treatment follow-up takes place.
The trial is designed as a double-blind study. This means that participants receive tablets indistinguishable among study groups, containing either a placebo or active compounds. Study team members will also remain blinded until data entry, processing, and database locking are completed.
The study’s main focus is on how often participants ovulate during and after the treatment. Additionally, they’re looking at a variety of aspects such as androgen levels (hormones linked to PCOS symptoms), various health measures, and even how the treatment impacts participants’ quality of life. In essence, the trial aims to thoroughly evaluate the SPIOMET treatment’s efficacy, tolerability, and safety.