AuthorisedTherapeutic use (Phase IV)Interventional

Optimizing metformin use in polycystic ovary syndrome - A randomized controlled trial

This research is looking closely at how to best use an existing medicine called Metformin for women who have Polycystic Ovary Syndrome (PCOS). We want to understand if different ways of taking Metformin can lead to better results. The study will check several important areas: changes in weight, hormone levels that can cause symptoms like unwanted hair growth, any tummy side effects like nausea or pain, and how the medicine affects the body's sugar and fat processes. It's a 'Phase IV' study, meaning the drug is already approved and used, but we're trying to fine-tune how it's given to get the most benefit for people with PCOS.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

HUS-yhtymae

Enrolment target

184

Start

06 Feb 2025

Polycystic ovary syndrome

What is this study about?

This study is all about helping women with a common condition called Polycystic Ovary Syndrome, or PCOS. PCOS can cause a range of symptoms, including irregular periods, difficulty getting pregnant, weight gain, and unwanted hair growth, among others. A medicine called Metformin is often used to help manage some of these symptoms, especially those related to how the body handles sugar and insulin. This research aims to find the very best way to use Metformin and understand its effects better.

The main things we'll be looking at are how Metformin affects a woman's weight, levels of certain hormones (like testosterone, which can cause symptoms such as extra hair), any stomach upsets the medicine might cause, and how it impacts the ovaries themselves. We'll also be checking how well the body processes sugar and fats. By understanding these effects better, doctors can make more informed decisions about prescribing Metformin to women with PCOS, hopefully leading to better health and fewer symptoms.

Ultimately, this study's goal is to improve the lives of women with PCOS. It's about making sure that the treatments available are used in the most effective way possible, helping to control symptoms and improve overall wellbeing. This isn't a new drug being tested for the first time, but rather a way to get more clarity on how an existing medication can be best used.

Key takeaways

This study aims to find the best way to use Metformin for PCOS.
It will look at effects on weight, hormones, and stomach issues.
Participation involves taking Metformin and having regular health checks.
It's for adult women diagnosed with Polycystic Ovary Syndrome.
The goal is to improve treatment options for women with PCOS.

Who may be eligible?

To be part of this study, you need to be a woman who has Polycystic Ovary Syndrome (PCOS). You must also be at least 18 years old, with no upper age limit mentioned.

This study is specifically looking for adult women diagnosed with PCOS. If you do not have PCOS, or if you are under 18, then this study would not be suitable for you.

There might be other health conditions or medications that would prevent you from taking part, even if you meet the age and PCOS criteria. These will be discussed with you by the study team if you express interest.

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 a woman?
Are you 18 years old or older?
Have you been diagnosed with Polycystic Ovary Syndrome (PCOS)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given Metformin to take, as this is the treatment being studied. Over the course of the study, you'll have several appointments. During these visits, the study team will carry out various assessments to see how you're responding to the treatment.

These assessments will likely include things like measuring your weight and blood pressure, taking blood samples to check hormone levels and how your body handles sugar and fats, and asking you questions about your periods, any stomach side effects you might be having (like nausea or tummy pain), and your overall wellbeing. They might also perform an ultrasound scan to look at your ovaries. You will be asked about your quality of life including feelings of anxiety.

Each visit may vary in length depending on the tests needed. The study will last for a certain period, and you'll have follow-up appointments throughout that time to track your progress and any changes. The total duration of your participation will be explained in detail by the study team.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as receiving treatment for your PCOS and having your health closely monitored by a medical team. We hope to learn more about how best to use Metformin for PCOS, which could help people in the future. However, there are also potential risks; Metformin can cause side effects like nausea, vomiting, or stomach pain, and there might be a risk associated with blood tests or other procedures. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Finland

Common questions

What is Polycystic Ovary Syndrome (PCOS)?

PCOS is a common condition that affects how a woman's ovaries work. It can cause irregular periods, higher levels of certain hormones, and sometimes small cysts on the ovaries.

What is Metformin?

Metformin is a medicine often used to help people with conditions like PCOS. It can help the body use insulin more effectively and lower blood sugar levels.

What will be checked in the study?

We'll check things like your weight, hormone levels, stomach side effects, how your body deals with sugar, and if there are any changes in your ovaries.

Is this a new medicine?

No, Metformin is an existing medicine that's already used. This study is about finding the best way to use it for women with PCOS.

Will I have to pay to join the study?

No, you should not have to pay to participate in the study. All study-related care and medication will be provided by the research team.