The effect of multiple doses of BI 425809 on the pharmacokinetics of multiple doses of a combination of ethinyl estradiol and levonorgestrel following oral administration in healthy premenopausal female subjects (an open-label, twoperiod, fixed sequence design trial with run-in period)
This research study is for healthy women and is designed to understand how a new medicine, called BI 425809, interacts with a common contraceptive pill (Microgynon). We want to see if taking BI 425809 at the same time as Microgynon changes how the contraceptive pill works in your body. This includes looking at how much of the contraceptive's active ingredients are in your blood and for how long. This type of study, called Phase I, is an early step in testing new medicines and helps us learn how they behave when given to people.
At a glance
What is this study about?
This study aims to find out what happens when a new medicine, called BI 425809, is taken alongside a common birth control pill like Microgynon. The birth control pill contains two active ingredients: levonorgestrel and ethinyl estradiol. Scientists need to understand if the new medicine changes how your body handles these ingredients. For example, does it make them stay in your body for a longer or shorter time? Or does it change how much of them get into your system overall? This information is really important because it helps ensure that new medicines can be safely taken with other common medications without affecting their effectiveness.
Think of it like this: if you take two different keys at the same time, you want to make sure one key doesn't stop the other key from working properly. In the same way, we need to check that a new medicine doesn't interfere with how your birth control pill protects you. By knowing exactly how these medicines interact, doctors can recommend the safest and most effective ways to use them in the future.
The main goal is to measure the amount of the birth control pill's ingredients in your blood over time. This helps us see if BI 425809 changes: 1) the total amount of the ingredients that get into your body, 2) the highest level they reach in your blood, and 3) the lowest level they reach. These measurements give us a clear picture of how the two medicines work together in your body.
Key takeaways
- This study examines how a new medicine interacts with a common birth control pill.
- It helps us understand if your birth control pill works differently when taken with the new medicine.
- Participation involves taking both medicines and providing blood samples.
- This is an early-stage study focusing on how medicines behave in the body.
- The study helps ensure future medicines can be used safely with birth control.
Who may be eligible?
This study is looking for healthy women aged 18 or older. You should be using a birth control pill like Microgynon, or be willing to start using it for the study. Being healthy means you don't have any major ongoing illnesses or conditions.
To be suitable for the study, you must not be pregnant or breastfeeding. You'll also need to agree to use effective contraception if you're not already on the pill being studied, or to stick to your current birth control method throughout the study period.
The research team will carry out some checks to make sure this study is safe and right for you. They will review your medical history and carry out some tests to confirm you are in good 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 a female aged 18 or older?
- Are you considered generally healthy by a doctor?
- Are you not pregnant or breastfeeding?
- Are you willing to take a specific contraceptive pill (Microgynon) during the study?
- Are you able to attend all clinic visits and provide blood samples?
What does participation involve?
If you decide to take part, you will be given both the new medicine, BI 425809, and the contraceptive pill (Microgynon) to take. There will be specific times when you'll need to visit the study clinic for check-ups and to give blood samples. These samples help the researchers measure the levels of the medicines in your body.
The study is split into different periods, and you'll take the medicines as instructed during these times. You'll have regular follow-up appointments and assessments to monitor your health and how you're reacting to the medicines. The exact number of visits and the total length of your involvement will be clearly explained by the study team, but it will involve repeat dosing and regular monitoring over a defined period.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is the new medicine, BI 425809, being tested for?
This study isn't testing BI 425809 for a specific illness; it's mainly to see how it interacts with a common birth control pill when taken together.
What is a 'human pharmacology' study?
This refers to an early stage of testing where researchers study how a new medicine moves through and affects the human body, focusing on safety and how it works.
Will I be given the birth control pill if I'm not already taking it?
Yes, if you meet the study criteria, you will be given the specific contraceptive pill used in the study (Microgynon) to take consistently.
How often will I need to give blood samples?
You will need to give blood samples at specific, regular times throughout the study period to measure the medicine levels. The schedule will be clearly explained.
Will my regular doctor know I'm in the study?
Usually, you would inform your regular doctor that you are participating in a clinical trial. The study team can discuss this with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.