SPIOMET4HEALTH’s solution-FAQs for the participants
SPIOMET4HEALTH is a European project that will perform a multi-centre clinical trial (involving 7 European centres and a total of 364 patients) to test a new treatment for Polycystic Ovary Syndrome (PCOS). The test will be based on the combination at low doses of 3 medications [spironolactone (SPI), pioglitazone (PIO) and metformin (MET)] within a single tablet (SPIOMET).
Here you will find the answer to many of the questions you may have before accepting to take part in the clinical trial study.
If you have more questions, please contact your doctor who will be able to answer all the questions that might not be included in this list.
General information on Clinical Trials
A clinical trial is a research study to answer specific questions about a new medical treatment (vaccines, new therapies, or new ways of using known treatments). Clinical trials are the primary way to find out if a new treatment is both safe and effective. They are also used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.
Blinding means that whoever is assessing the effects of the treatment will not know if they are studying patients on the treatment or patients on a placebo. This helps to prevent bias. If you are part of a ‘single blind’ trial, you will not know which treatment you are receiving. If you take part in a ‘double-blind’ trial, neither you nor your doctor will know which treatment you are receiving. The aim is to make sure that nobody’s expectations affect the results of the trial.
A placebo is a pill that does not contain any active medication, sometimes called a “sugar pill”. A placebo is used in clinical trials to test the effectiveness of treatments.
SPIOMET4HEALTH will be a multi-centre, double-blinded, randomised-controlled Phase II clinical trial.
Inclusion criteria are a set of predefined characteristics used to identify subjects who will be included in a research study.
Most clinical trials are randomised trials. In a randomised trial subjects are randomly (by a computer and not by a doctor) assigned to one of two or more groups: one group receiving the treatment that is being tested, and the other(s), the comparison group(s) receiving an alternative treatment or a placebo. The groups are then followed up to see if there are any differences between them in outcome.
Clinical trials are divided into 4 different stages, called phases.
- Phase I: trials aim to test the safety of various doses of a new medication.
- Phase II: trials test the new medication in a larger group of people who are ill, to see whether it has any effects suggesting that it might help them.
- Phase III: trials test new medication in larger groups of people who are ill. Phase 3 trials compare the new medication with whatever treatments are currently in use, or occasionally with a placebo.
- Phase IV: studies are designed to provide broader experience in evaluating the safety and effectiveness of the new medicine in larger numbers of patients, subgroups of patients, and to compare and/or combine it with other available treatments.
PCOS is the most common endocrine-metabolic disorder among women of reproductive age, affecting 5-10% of women worldwide. This syndrome is the most frequent cause of anovulatory subfertility, and it is associated with other lifelong disorders like type 2 diabetes, premenopausal cancer and anxiety/depression, with a negative impact on the health and quality of life of these subjects and their offspring.
There is currently no approved treatment for PCOS in adolescent girls and young women. Oral contraceptives (OCs) are prescribed off-label to approximately 98% of young PCOS patients, including to those without pregnancy risk. OCs do alleviate key symptoms of PCOS, such hirsutism and menstrual irregularity, but do not revert the underlying pathophysiology, and patients remain at risk for post-treatment subfertility.
Pilot studies developed by Prof. Lourdes Ibáñez and Prof. Francis de Zegher performed at Hospital Sant Joan de Déu have generated new insights into the pathophysiology of PCOS, and have thus led to the development of a new approach wherein the PCOS phenotype is reverted without side effects. The novel medication is a fixed, low-dose combination of two insulin sensitisers [pioglitazone(PIO), metformin (MET)] and one mixed anti-androgen and anti- mineralocorticoid [spironolactone(SPI)] (SPIOMET). The new treatment is superior to OCs in normalising ovulation rates and the endocrine-metabolic alterations, apparently without side effects.
However, the studies performed so far had some limitations: the medications had to be administered separately, resulting in the intake of three different tablets. Those studies were unblinded, included mostly patients without obesity and had limited ethnic variability so that the conclusions were not readily applicable to the entire PCOS population. SPIOMET4HEALTH will overcome those limitations by giving the three medications in a single tablet, by comparing the effects of this triple tablet with those of a tablet containing two or one of the components, or placebo, and by having a double-blind nature, so that neither the patient nor the physician who treats her will know which medication is being administered.
Exclusion criteria are those characteristics that disqualify prospective subjects from inclusion in the study.
Inclusion criteria, along with exclusion criteria, make up the selection or eligibility criteria used to rule in or out the target population for a research study.
About taking part in SPIOMET4HEALTH Clinical Trial
Adolescent girls and young adult women, aged between 12 and 24 years old, who have been diagnosed with PCOS.
Patients will be recruited at 7 hospitals across Europe: Hospital Sant Joan de Déu (Barcelona, Spain), Fundació Institut D’investigacio Biomedica De Girona Doctor Josep Trueta (Girona, Spain), Medizinische Universitat Graz (Graz, Austria), Region Syddanmark (Odense, Denmark), Norges Teknisk-Naturvitenskapelige Universitet (Throndeim, Norway), Alma Mater Studiorum – Universita Di Bologna (Bologna, Italy), Istanbul Universitesi (Istanbul, Turkey).
Every 3 months.
SPIOMET4HEALTH will be a randomised trial. Thus, the subjects will be randomly assigned (by a computer and not by a doctor) to one of the interventions described above.
Deciding to participate in a clinical trial, or not, or withdraw from the trial at any time during its course, will not affect the care you receive from your doctor.
The medication will not be readily available, but we anticipate that the patients who will receive SPIOMET will be free of symptoms at the end of the treatment phase.
Your family doctor will be the main responsible for your general care beyond the aspects related to PCOS.
Recruitment will start on April 1, 2022 and will end on September 30, 2023.
The process of informed consent occurs when communication between a patient and a physician results in the patient’s authorisation or agreement to undergo a specific medical intervention.
The patient must be given all the information about what the treatment, including its benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment does not go ahead.
Informed consent has four components including decision capacity, documentation of consent, disclosure, and competency.
Signing an informed consent means:
- You have received all the information about your treatment options from your health care provider.
- You understand the information and you have had a chance to ask questions.
- You use this information to decide if you want to receive the recommended treatment option(s) that have been explained to you. Sometimes, you may choose to receive only part of the recommended care. Talk to your health care provider about your options.
If you agree to receive all or some of the treatment options, you give your consent (agree) by signing a consent form. The completed and signed form is a legal document that lets your doctor go ahead with the treatment plan.
The EU General Data Protection Regulation – GDPR – aims to standardise and strengthen the protection of personal data across the EU and for other country’s data being “processed” within the EU, since May 2018. The GDPR also applies for Clinical trials.
If the person confirms its participation in a trial, data can be only processed for the purpose of that trial. The EU GDPR requires that personal data is collected for specified, explicit and legitimate purposes and not further processed in a manner that is incompatible with those purposes.
An individual has the right to withdraw his/her consent at any time during the conduct of the clinical trial. This information should be given to the patients prior to giving their consent to participate in the clinical trial.
SPIOMET4HEALTH will be a double-blinded study. Thus, neither the patient nor the members of the research team will know which medication each patient will receive during the study.
All the results from the clinical studies, including analysis of endocrine-metabolic and imaging variables, will be delivered to the patient after the doctor reviews the contents.
If you want to participate, the researchers at your hospital will explain in detail the study.
Participation in the trial is voluntary and you can decide not to participate or change your decision and withdraw from the trial at any time during its course, without this affecting your medical care and without having to give explanations.