Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A drug-drug interaction trial in healthy female participants to investigate the effect of aprocitentan on combined hormonal contraceptives.

This research study is for healthy women and is focused on understanding if a new medication, called aprocitentan, affects how well combined hormonal contraceptives (like the pill, patch, or ring) work. This is an early stage of testing new medicines, often called 'Phase 1', where scientists check how medicines interact in the human body. By taking part, you would help researchers learn if aprocitentan changes the levels of your birth control hormones, which is important for ensuring the new medicine can be used safely alongside common contraception methods. It's not about treating an illness, but about gathering important safety information.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Idorsia Pharmaceuticals Ltd.

Enrolment target

Start

10 Dec 2024

Not applicable - healthy volunteer trial

What is this study about?

Imagine you're taking two different medicines — say, a new cold remedy and your usual birth control. Sometimes, one medicine can affect how the other one works. This study is designed to explore exactly that kind of situation, but with a new medicine called aprocitentan and common hormone-based birth control methods.

The main goal is to see if aprocitentan changes the levels of the hormones in your combined oral contraceptive (like the pill) or other similar methods. Why is this important? Because if aprocitentan makes your birth control less effective, that's crucial information for doctors and patients to know. This study is happening at a very early stage of testing new medicines, before they are widely used, to gather fundamental safety and interaction data.

By taking part in a study like this, healthy volunteers play a vital role in medicine discovery. You help researchers understand how potential new treatments behave in the human body, ensuring that when new medicines become available, they can be used safely and effectively alongside other common medications. This particular study doesn't aim to treat any specific condition; instead, it's about learning about drug interactions.

Key takeaways

This study is for healthy women.
It investigates how a new medicine interacts with common hormone birth control.
The goal is to ensure safe use of new medicines alongside contraception.
Participants help advance medical knowledge.
You will be closely monitored by a medical team.

Who may be eligible?

This study is looking for healthy women to take part. To be eligible, you need to be at least 18 years old – there isn't an upper age limit mentioned, so women of many different ages could potentially join.

Because the study is specifically looking at how a new medicine interacts with hormone-based birth control, a key requirement will likely be that you are currently using, or willing to use, a combined hormonal contraceptive. This might include certain types of birth control pills, patches, or vaginal rings. The research team will need to confirm you are in good general health before you can join.

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 generally in good health?
Are you currently using, or willing to use, a combined hormonal contraceptive?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to a clinic over a period of time. You would be given the new medicine, aprocitentan, and continue to take your combined hormonal contraceptive as usual. The study team would regularly take blood samples to measure the levels of both the new medicine and the hormones from your birth control to see if they affect each other. You would also have regular health checks, such as blood pressure readings and possibly urine tests. The exact number of visits, assessments, and the overall duration of the study would be fully explained to you before you decide to take part. There will be careful monitoring throughout.

Potential risks and benefits

The main benefit of taking part in this study is contributing to medical science and helping to ensure the safe development of new medicines. While there's no direct personal health benefit for participants, the information gained is incredibly important. As with any medical study, there are potential risks, such as side effects from the new medicine or discomfort from blood tests. All known and potential risks will be thoroughly explained to you, and your safety will be closely monitored throughout the study. Remember, you can choose to withdraw from 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
Czechia

Common questions

What is 'aprocitentan'?

Aprocitentan is the name of a new medicine being tested. This study helps us learn more about it.

What are 'combined hormonal contraceptives'?

These are common types of birth control that contain two different hormones, like many birth control pills, patches, or vaginal rings.

Will I get free contraception if I join?

The study aims to observe existing contraception use. Specific arrangements for contraception will be discussed by the study team.

Will taking part affect my ability to get pregnant after the study?

There is no indication this study impacts future fertility, but you should discuss any concerns with the study doctor.

Do I have to stop my birth control for this study?

No, you will likely continue your birth control as usual, as the study wants to see how the new medicine interacts with it.