A study in healthy women to test whether BI 1358894 influences the amount of a contraceptive in the blood
This study is for healthy women and is testing a new investigational medicine called BI 1358894. Researchers want to find out if this new medicine changes how much of a common contraceptive enters the bloodstream and how long it stays there. This type of study is important because it helps scientists understand if different medicines can affect each other when taken at the same time. The goal is to make sure medicines are safe and effective when used together. This early-stage study carefully measures how the body handles the medicine to make sure it's understood before it can be developed further. It's an important step in making sure new medicines can be safely used by people.
At a glance
What is this study about?
This study is about a new medicine called BI 1358894 and how it might interact with a contraceptive you might be taking. When you take different medicines at the same time, they can sometimes affect how each other work. For example, one medicine might make another medicine less effective, or it might make it stay in your body for longer or shorter periods than usual. This study is specifically looking at whether BI 1358894 changes the amount of a contraceptive that gets into your blood.
The main purpose of this research is to see if BI 1358894 has any impact on the levels of a contraceptive in the body. By understanding how the new medicine affects the contraceptive, doctors and scientists can work out how to use these medicines together safely in the future. This is a very early stage of testing for the new medicine and is a crucial step in its development.
This kind of study, sometimes called a 'pharmacokinetic trial,' is like checking the 'journey' of a medicine in your body. It helps us understand how much of the medicine gets absorbed, how it travels around, and how quickly it leaves the body. This information is vital for ensuring any new medicine is safe and works properly, especially when people might be taking other regular treatments like contraceptives.
Key takeaways
- This study is testing a new medicine in healthy women.
- It aims to see if the new medicine affects a common contraceptive in the blood.
- Participation involves taking medicines and having blood tests.
- It's an early-stage study to understand how medicines interact.
- You must be a woman aged 18 or older to potentially join.
- You can withdraw from the study at any time.
Who may be eligible?
This study is specifically looking for healthy women aged 18 years and older. There isn't an upper age limit mentioned, so if you're a woman over 18 and generally in good health, you might be able to take part.
Being 'healthy' for a study usually means you don't have any major ongoing medical conditions that require treatment and you aren't taking medicines that could interfere with the study. The study team will do some checks to make sure you fit the health requirements, as this helps to make sure the results of the study are clear and accurate.
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?
- Am I 18 years old or older?
- Do I consider myself generally healthy?
- Am I comfortable taking a contraceptive as part of the study?
- Am I willing to attend several clinic visits for tests and monitoring?
What does participation involve?
If you decide to take part, you'll have several visits to the study clinic. During these visits, nurses and doctors will monitor your health, take blood samples, and ask you to take the study medicines (BI 1358894 and a contraceptive). The blood samples will help researchers measure the levels of the medicines in your body over time. You might also have other checks like blood pressure readings or heart rate measurements.
The total duration of your participation, including all visits and any follow-up, will be clearly explained by the study team. You'll receive specific instructions on how and when to take the medicines, and what to expect during each visit. Make sure to ask any questions you have about the schedule and what's involved.
Potential risks and benefits
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Common questions
What does 'healthy women' mean for this study?
It means you generally don't have any major medical conditions, and aren't on medications that could affect the study's results. The study team will do checks to confirm this.
Will I receive the new medicine BI 1358894?
Yes, if you qualify and choose to participate, you will receive the investigational medicine BI 1358894 as part of the study plan.
Will I take a contraceptive during the study?
Yes, part of the study involves taking a specific contraceptive alongside BI 1358894, as the study aims to see how they interact.
How long will I need to be involved in the study?
The total length of participation, including all visits and follow-ups, will be fully explained by the study team before you agree to take part.
Can I stop participating in the study if I change my mind?
Yes, you are free to withdraw from the study at any time, for any reason, without needing to explain why, and it won't affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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