A study to investigate the effects of multiple doses of obefazimod on a combined oral contraceptive (ethinyl estradiol/drospirenone) in healthy female participants of childbearing potential.
This research study is about understanding how a new medicine called obefazimod interacts with a specific type of oral contraceptive pill, commonly known as 'the pill' (which contains ethinyl estradiol and drospirenone). We are inviting healthy women who are able to have children to take part. The main goal is to see if taking obefazimod at the same time as this birth control pill changes how either medicine works in the body. This is important to ensure that if obefazimod is ever used widely, we understand its effects on birth control and can advise women safely. It's a very early stage study, focusing on how these medicines behave in the body.
At a glance
What is this study about?
This study is designed to explore how a new medicine, called obefazimod, might interact with a common type of oral contraceptive pill. This pill contains two active ingredients: ethinyl estradiol and drospirenone, and is widely used for birth control. When two different medicines are taken at the same time, they can sometimes affect how each other works in the body. One medicine might make the other stronger or weaker, or change how quickly it's removed from the body.
The main purpose of this study is to find out if obefazimod changes the way your body handles the birth control pill, and vice versa. This is really important because if obefazimod affects the birth control pill, it could make the pill less effective at preventing pregnancy, or potentially lead to unexpected side effects.
By understanding these interactions early on, researchers can make sure that if obefazimod becomes a widely used medicine, doctors will know how to safely prescribe it, especially for women who are also using this type of birth control. This study helps ensure the safety and effectiveness of both medicines when taken together.
Key takeaways
- This study looks at how a new medicine affects a common birth control pill.
- It's for healthy women who can have children and use a specific birth control pill.
- The goal is to ensure medicines are safe when taken together.
- Participation involves clinic visits, taking medicines, and blood tests.
- You'll get full information on potential risks and benefits before deciding.
Who may be eligible?
This study is looking for healthy women who are able to become pregnant. This means you should be between 18 years old and typically up to about 50 years old, as long as you are still having regular periods. You will need to be in good overall health, without any major ongoing medical conditions.
Because we are looking at how a birth control pill works, it's important that you are already using, or are willing to use, a specific type of combined oral contraceptive pill containing ethinyl estradiol and drospirenone. The study will need to confirm you are healthy enough to take part through medical checks.
If you have certain medical conditions, are taking other medicines that might interfere with the study drugs, or have any allergies to the study medications, you might not be able to participate. The study team will review all your medical information carefully to see if this study is right for you.
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 female and at least 18 years old?
- Are you generally healthy?
- Are you able to become pregnant (not gone through menopause)?
- Are you currently using, or willing to use, a birth control pill with ethinyl estradiol and drospirenone?
- Are you willing to attend regular clinic appointments?
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 doses of the new medicine, obefazimod, as well as your regular birth control pill. During these visits, the study team would take regular blood samples to measure how the medicines are working in your body. You might also have other check-ups like blood pressure readings and general health assessments.
The study would involve taking the medicines as instructed by the study team. You would be given a schedule for when to take the medicines and when to come in for appointments. There will also be follow-up appointments after you finish taking the study medicines, to make sure you are well. The total time you would be involved in the study would depend on the specific schedule, but it could range from several weeks to a few months, including follow-up.
Potential risks and benefits
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Common questions
What is obefazimod?
Obefazimod is a new medicine being studied. We are looking into how it works and whether it interacts with other common medicines like birth control pills.
Why are you studying birth control pills?
We want to see if obefazimod affects how a standard birth control pill works in your body. This helps us ensure that if obefazimod is used in the future, it's safe for women who also take birth control.
Will my birth control still work?
The study will specifically look at this. You will be given clear guidance on what to do to prevent pregnancy, including possibly using extra forms of birth control, to ensure your safety.
How long will I be in the study?
The exact length varies, but it will involve a series of visits and medication periods, followed by some check-ups. The study team will tell you the precise duration.
Do I have to take part?
No, taking part is completely voluntary. You can choose not to participate, or you can withdraw at any time without it affecting 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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