Study to assess the relative bioavailability of Neludolat versus YAZ in healthy female subjects.
This early-stage research study compares a study medicine named Neludolat with an established contraceptive pill called YAZ. The researchers want to understand how Neludolat is absorbed, broken down, and cleared by the body compared to YAZ. This type of test is called a bioavailability study. Taking part helps scientists find out if the new treatment delivers the same amount of active ingredients into the bloodstream as the existing pill. Because this is an early safety and pharmacology test, the study is open to healthy female volunteers aged 18 and older. Participants will take the tablets under medical supervision, have regular blood samples taken to measure medicine levels, and receive routine health monitoring. There is no direct medical benefit to participants, but taking part helps researchers develop potential new treatment options for women in the future.
At a glance
What is this study about?
Every new medicine needs careful testing before it can be made widely available. In this early clinical trial, researchers are comparing a medicine called Neludolat with YAZ, an existing contraceptive pill that has been used safely for many years. The main goal is to measure how much of the medicine gets into the bloodstream and how quickly this happens.
When scientists compare a new medicine to a well-known one, they look at something called 'bioavailability'. This simply means tracking how the body absorbs, uses, and gets rid of the tablet. By checking blood samples at set times after each pill is taken, doctors can see whether Neludolat behaves in the body in a way that matches expectations based on YAZ.
This kind of study matters because it provides the vital building blocks for future treatments. If the new medicine behaves reliably in healthy volunteers, researchers can take the next steps to understand whether it could become a helpful option for women who need treatment in the future.
Key takeaways
- This is an early-stage study comparing Neludolat with the established pill YAZ in healthy women.
- The main aim is to measure how the body absorbs and clears the medicine from the bloodstream.
- Participants must be healthy women aged 18 or older.
- Taking part involves clinic visits, health checks, taking study tablets, and regular blood tests.
- There is no direct health benefit to volunteers, and you may leave the study at any time.
Who may be eligible?
This trial is looking for healthy adult women who are at least 18 years old. Because this is an early-stage study designed to understand how the body processes the medicine, researchers need volunteers who do not have serious ongoing medical conditions.
To be considered healthy for this study, you should generally be in good overall health, without major heart, liver, kidney, or blood clotting problems. The study team will run a full health check, including blood tests and a physical exam, to make sure it is safe for you to take part.
You may not be able to join if you take certain regular prescription medicines, if you smoke heavily, or if you have a history of blood clots, as these factors can interfere with the study results or increase your risk of side effects.
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.
- I am a woman aged 18 years or older.
- I consider myself to be in good general health.
- I do not have a history of blood clots, heart problems, or liver disease.
- I am comfortable having routine blood tests taken.
- I am able to attend clinic visits and follow the study schedule.
What does participation involve?
If you take part, you will first attend a screening visit where the medical team will check your general health, take your medical history, and run routine blood and urine tests. If you are eligible, you will be invited to join the main study. This usually involves staying at a specialist clinical research unit for a short period or attending several planned visits. During the trial, you will be given the study tablets to take at set times. The clinical team will monitor your blood pressure, heart rate, and temperature, and will take small blood samples at regular points over the day to measure the levels of medicine in your blood. After the testing period is complete, you will have a final follow-up visit so the doctors can check that you are feeling well before you finish the study.
Potential risks and benefits
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Common questions
What is the purpose of this study?
The study aims to compare how the body absorbs and processes a new medicine, Neludolat, compared to an approved pill called YAZ.
Will taking part protect me from pregnancy?
No. You should not rely on the study medicines for contraception during this trial. The study team will explain what reliable birth control methods you must use.
Do I have to pay to take part?
No, all study medicines, tests, and medical visits are provided at no cost. Many trials also offer compensation for your time and travel expenses.
How many blood samples will be taken?
Multiple blood samples are needed over several hours to measure drug levels precisely. The study team will explain the exact schedule before you decide to join.
Can I leave the trial if I change my mind?
Yes. Taking part is entirely voluntary, and you are free to stop at any point without it affecting your standard medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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