A Study in Germany to Learn About the Value of Fezolinetant in Treating Hot Flashes and Night Sweats in Women During Menopause
This study is for women in Germany who are experiencing hot flashes and night sweats (sometimes called vasomotor symptoms) during menopause. They will be taking a non-hormonal tablet called fezolinetant, which their doctor has prescribed to help with these symptoms. Fezolinetant is already approved in some countries for this purpose. The main goal of this study is to gather information on how effective fezolinetant is at treating hot flashes and night sweats in women during menopause in their everyday lives. Participants will take the tablets as directed by their doctor and will complete a series of online check-ups and surveys over about six months to share their experiences.
At a glance
What is this study about?
Many women going through menopause experience uncomfortable symptoms like hot flashes and night sweats. These symptoms can be disruptive to daily life. Doctors have different ways to help manage these symptoms, and one option is a non-hormonal tablet called fezolinetant. This medication has been approved in some parts of the world to treat hot flashes and night sweats.
This particular study, taking place in Germany, isn't about testing if fezolinetant works – that's already known in some areas. Instead, it's about learning more about its real-world value and how helpful it is for women who are already being treated with it by their doctor. It helps us understand how the medication performs in everyday situations, not just in a controlled trial.
The study will collect information from women who have been prescribed fezolinetant by their doctor for their menopause symptoms. By asking about their experiences, researchers hope to get a clearer picture of how fezolinetant helps with hot flashes and night sweats, and how it impacts women's overall well-being and daily routines during menopause.
Key takeaways
- This study is for women in Germany with menopausal hot flashes and night sweats.
- It aims to understand the real-world value of fezolinetant treatment.
- Fezolinetant is a non-hormonal tablet already prescribed by participants' doctors.
- Participation involves virtual surveys and check-ups over six months.
- You must be able to use digital tools and communicate in German.
- Your doctor makes all treatment decisions, not the study.
Who may be eligible?
To be part of this study, you must be a woman living in Germany who has been prescribed fezolinetant by your doctor specifically for hot flashes and night sweats related to menopause. You also need to be able to speak and understand German.
Since the study involves online check-ups and surveys, you must be comfortable using digital tools and have access to a device (like a computer, tablet, or smartphone) that can connect to the internet.
You cannot join this study if you are already taking part in another clinical trial. This helps make sure that the information collected for this study is not influenced by other ongoing research.
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.
- Am I a woman currently living in Germany?
- Has my doctor prescribed me fezolinetant for my hot flashes and night sweats during menopause?
- Can I speak and understand German?
- Do I have access to the internet and feel comfortable using online tools for surveys?
- Am I currently participating in any other medical research studies or clinical trials?
What does participation involve?
If you decide to take part, you will continue taking fezolinetant tablets for your hot flashes and night sweats as prescribed by your doctor. The study itself will last for about six months (24 weeks).
During these six months, you'll have up to five 'virtual reviews.' These are online check-ups where you will be asked to fill out 3 to 5 surveys. The first virtual review will ask about your general health and any other medications you've taken or are currently taking.
After your first or second virtual review, you'll start taking fezolinetant. You'll then have three more virtual follow-up reviews: one about a week after starting the medication, another around three months (12 weeks) later, and a final one at six months (24 weeks). These surveys will ask about your hot flashes, night sweats, other menopause symptoms, and how these affect your health and daily life. You'll also be asked if you've taken your fezolinetant tablets as prescribed or if you've stopped taking them.
Potential risks and benefits
Locations (1)
- Site DE49001Verified postcodeBerlin, Germany
Common questions
What kind of symptoms does this study focus on?
It focuses on hot flashes and night sweats, which are common symptoms women experience during menopause.
Is fezolinetant a hormone therapy?
No, fezolinetant tablets are not a hormone treatment. They work in a different way.
Who is paying for this study?
The study sponsor is Astellas, a pharmaceutical company, but your doctor makes all treatment decisions, not them.
How often will I need to do surveys?
You'll complete surveys during up to five virtual reviews over about six months.
Do I have to visit a clinic for this study?
No, all reviews are virtual, meaning they are done online from your home.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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