A Phase II, randomised, multi-centric, multi-national clinical trial to evaluate the efficacy, tolerability, and safety of a fixed dose combination of Spironolactone, Pioglitazone & Metformin (SPIOMET) for adolescent girls and young adult women (AYAs) with polycystic ovary syndrome (PCOS).
This research is a Phase II clinical trial investigating a new combination of medicines called SPIOMET for teenage girls and young women who have Polycystic Ovary Syndrome (PCOS). PCOS can cause irregular periods and other symptoms. The main goal of the study is to see if SPIOMET can help participants ovulate (release an egg from their ovary) more regularly, both during and after treatment. Researchers will also be carefully checking how safe the new medication is and how well people tolerate it, looking for any side effects. This study aims to find more effective ways to manage PCOS symptoms and improve women's health.
At a glance
What is this study about?
This study is a clinical trial, which means it's a careful research study involving people. It's looking into a new treatment for Polycystic Ovary Syndrome (PCOS), a common condition affecting many women. PCOS can cause various symptoms like irregular periods, difficulty getting pregnant, acne, and excess hair growth. Current treatments often help manage these symptoms, but researchers are always looking for better options.
The new treatment being tested is a combination of existing medicines called SPIOMET. This study is in Phase II, which means it's one of the earlier stages of research. Scientists are focused on finding out if the treatment works as intended, mainly by seeing if it helps women with PCOS to ovulate more regularly. Ovulation is when an egg is released from the ovary, a key part of a regular menstrual cycle. They will be comparing SPIOMET to individual medications or a dummy pill (placebo) to understand its effects better.
Beyond ovulation, the research team will also be keeping a close eye on other important aspects of health. This includes checking general health measures like weight, blood pressure, and hormone levels, which are often affected by PCOS. They will also look at how the body handles sugar and fats, and even use scans like MRI to see how the treatment might affect body composition and fat distribution. Importantly, they will carefully monitor for any side effects to make sure the treatment is safe and well-tolerated for those who take it. The aim is to find new and effective ways to help manage PCOS and improve the lives of young women with the condition.
Key takeaways
- This study is testing a new combined medicine, SPIOMET, for young women with PCOS.
- The main goal is to see if SPIOMET helps regularise ovulation.
- Researchers will also carefully check for side effects and how well the treatment is tolerated.
- It's a Phase II trial, an early step in finding new treatments for PCOS.
- Participation involves regular clinic visits, health checks, and taking study medication.
- You can withdraw from the study at any time.
Who may be eligible?
This study is specifically looking for young women who have Polycystic Ovary Syndrome (PCOS).
To be considered for this study, you must be female and aged 18 years or older. There is no upper age limit mentioned, meaning women over 18 can potentially join.
Other specific medical criteria will be assessed by the study team to ensure you are a good fit for the trial and that it is safe for you to participate. This will likely involve reviewing your medical history and current health.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you female?
- Are you 18 years old or older?
- Have you been diagnosed with Polycystic Ovary Syndrome (PCOS)?
- Are you able to attend regular clinic appointments?
What does participation involve?
If you decide to take part in this study, you would be given one of the study medications (SPIOMET, its individual components, or a placebo) to take. You would have regular visits to the hospital or clinic for check-ups throughout the study. During these visits, the research team would carry out various assessments. These include measuring your height, weight, and blood pressure, and taking blood samples to check hormone levels, blood sugar, and other health markers. You might also have scans like ultrasounds or MRI scans to look at your ovaries and other parts of your body. You'll be asked to fill out questionnaires about your lifestyle, diet, and how you're feeling. The study involves taking medication for a period, and there will be follow-up appointments after you finish taking the medication to see its longer-term effects. The total duration of your participation, including follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (5)
- —UnverifiedAustria
- —UnverifiedSpain
- —UnverifiedDenmark
- —UnverifiedNorway
- —UnverifiedItaly
Common questions
What is PCOS?
PCOS stands for Polycystic Ovary Syndrome. It's a common hormone problem in women that can cause irregular periods, acne, excess hair, and can make it harder to get pregnant.
What is a Phase II trial?
A Phase II trial is an early stage of clinical research where scientists want to see if a new treatment works, how well it's tolerated, and to find the right dose. It involves a small group of people.
What is SPIOMET?
SPIOMET is a new combination of existing medicines being tested in this study to see if it can help women with PCOS.
Will I know if I'm getting the new treatment or a dummy pill?
This is a 'randomised' study, meaning you'll be assigned to a group by chance. Often, in these types of studies, neither you nor your doctor will know which treatment you are receiving (this is called 'blinded').
What does 'ovulation rate' mean?
Ovulation rate refers to how often a woman releases an egg from her ovary. A regular ovulation rate is important for predictable periods and fertility.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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