Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in women with overweight or obesity to test whether different doses of BI 456906 influence the amount of a contraceptive in the blood

This research study is for women who are overweight or obese, and it's designed to understand how a new investigational medication, called BI 456906, interacts with a type of contraception. Specifically, the study will measure how different doses of BI 456906 might change the levels of a contraceptive in a woman's blood. This is important because it helps us understand if the new medicine could affect how well birth control works. This type of study, often called a 'pharmacokinetic trial,' is an early step in testing new medicines to make sure they are safe and interact with other medications as expected.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

16 Aug 2023

pharmacokinetic trial

What is this study about?

Imagine you're trying a new food, and you want to know if it changes how another food you usually eat tastes. This study is a bit like that, but with medicines. We're looking at a new investigational medication, called BI 456906, and how it might affect the levels of a contraceptive in the blood of women who are overweight or obese. Contraceptives are medicines used to prevent pregnancy.

When you take a medicine, your body processes it. This study wants to see if BI 456906 changes how your body handles a contraceptive. We'll be giving different amounts (doses) of BI 456906 and then checking blood samples to measure the contraceptive levels. This helps us understand if the new medicine might make a contraceptive less or more effective.

This kind of study is an early stage of testing new medications. It's really important because it helps scientists understand how different medicines interact within the body. This information is vital for ensuring that new medicines are safe to use, especially when people are also taking other medications like birth control.

Key takeaways

This study looks at how a new medicine affects a contraceptive.
It's for women who are overweight or obese, aged 18 and over.
Participation involves clinic visits and blood tests.
The aim is to ensure new medicines are safe and work as expected with other medications.
You can stop participating at any time.

Who may be eligible?

This study is looking for women who are at least 18 years old. There is no upper age limit, meaning women of any adult age can take part.

To be eligible, you'll also need to be considered overweight or obese. This is usually determined by a measurement called Body Mass Index (BMI). Specific health checks will be done by the study doctors to make sure you fit all the safety requirements for the study.

More detailed medical checks will be done to make sure the study is right for you, and that you don't have any health conditions or are taking any medications that would make it unsafe for you to participate.

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?
Are you considered overweight or obese?
Are you able to attend regular clinic visits and have blood tests?
Are you willing to use specific contraception during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would need to visit the study clinic regularly. During these visits, the study team would give you the investigational medication (BI 456906) and the specific contraceptive. Blood samples would be taken at different times to measure the levels of the contraceptive in your body. You would also have regular health checks, including physical exams and other tests to monitor your well-being. The exact number of visits, tests, and the total length of time you'd be involved will be fully explained by the study team before you decide to join.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. You might not directly benefit from taking part in this specific study, but the information we learn could help other women in the future. As with any medication, there's a chance you might experience side effects from the investigational medicine or the contraceptive used in the study. All procedures will be explained in detail, and doctors will monitor your health closely. Remember, you can choose 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
Germany

Common questions

What is BI 456906?

BI 456906 is a new medication that is being researched. It's not yet available to the public and is still in the early stages of testing.

What does 'pharmacokinetic' mean?

It's a scientific word that simply means we're studying how the body handles a medicine – how it's absorbed, distributed, broken down, and leaves the body.

How will my birth control be affected?

That's exactly what the study is trying to find out! We will be carefully monitoring the levels of a contraceptive in your blood to see if BI 456906 changes them.

Will I know my results?

While you won't get individual results from the blood tests as they happen, the overall findings of the study will be used to better understand the medication.

Do I have to be pregnant to join?

No, this study is not for pregnant women. In fact, participants will need to use a specific form of contraception during the study.