The clinical trial - SPIOMET4HEALTH

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SPIOMET4HEALTH’s solution

The SPIOMET4HEALTH project represents a potential treatment for PCOS that focuses on tackling the syndrome at its root, rather than merely relieving its symptoms.

This treatment combines three medications that have already proven to be effective in the past, in a single tablet. Combining SPI (spironolactone)-PIO (pioglitazone)-MET (metformin), SPIOMET, administered daily, together with lifestyle measures, could normalise ovulation and hormones, and thus revert the alterations associated to PCOS.

This new solution could improve the quality of life for millions of women around the world and save 0,5 and 1.0 billion euros per year for the health care system.

SPIOMET4HEALTH will conduct a trial in seven different centres to achieve this goal. The data will be crucially helpful to develop new strategies for women’s health and to reduce the economic burden of PCOS on health systems.

WHY IS THE TRIAL FOCUSING ON ADOLESCENT GIRLS AND YOUNG WOMEN?

SPIOMET4HEALTH focuses on adolescent girls and young adult women , since intervening at an early stage can be beneficial, not only for the patients in the long term, but also for their future offspring.

An early intervention is vital to avoid subfertility, the risk for premenopausal endometrial cancer and other associated disorders. Additionally, it is also essential to help adolescents and young women live a healthy and non-stigmatised life.

A SINGLE TABLET

SPIOMET4HEALTH intends to facilitate the access to PCOS treatment by developing a single tablet that contains the three medications that, in many countries, may not be available separately in appropriate doses.

The use of a single tablet, instead of three different ones, will facilitate the adherence to the treatment.

WHO CAN PARTICIPATE?

Age: 12-23 years

Irregular menstrual periods

Excess body hair

THE TRIAL

Clinical trials are normally divided into different stages, called phases:

Phase I

In this phase, the safety of a new drug is tested in various doses.

Phase II

The new drug is tested in a larger group of people who are ill, to see if it has any positive effects. SPIOMET4HEALTH is here.

Phase III

Trials compare the new drugs with whatever treatments are currently in use, or occasionally with placebo treatments (no active medication, sometimes called a 'sugar pill’).

Phase IV

The safety and effectiveness of the new medicine is evaluated in larger numbers of patients, subgroups of patients, and compared and combined with other available treatments.

SPIOMET4HEALTH will perform a Phase II clinical trial. The study will be conducted in seven tertiary hospitals from 4 European Member States and 2 associated countries: