Phase 1, Randomized, Open-label, Single center study to evaluate Pharmacokinetic and Bioequivalence of Levonorgestrel Vaginal Delivery System in Healthy Female Volunteers after different days of use
This early-stage clinical trial is testing a new vaginal delivery system for a hormone called levonorgestrel. Levonorgestrel is already widely used around the world in birth control pills, coils, and emergency contraception. In this study, healthy female volunteers will test a flexible device placed in the vagina. Researchers want to find out how the hormone enters the bloodstream and how the body handles it over different periods of time. This type of research is called a pharmacokinetic and bioequivalence study. Because this is a Phase 1 study, the main goal is not to treat an illness, but to understand the science of how the body absorbs the medicine from the device. The findings will help scientists design simpler, more reliable, and longer-lasting contraceptive options for women in the future.
At a glance
What is this study about?
Many women use contraception to plan if and when they want to have children. Levonorgestrel is a well-known, safe type of man-made hormone called a progestogen. It is already used in everyday contraceptive pills, implants, and intrauterine systems (coils). Researchers are now testing a new way to deliver this medicine using a soft device placed directly inside the vagina.
This trial is a Phase 1 study. That means it is an early step in medical research. Doctors want to see how the hormone is absorbed into the bloodstream when the device is worn for different lengths of time. They will measure drug levels in the blood to make sure the device releases a steady and predictable amount of medicine.
Learning how the body processes the hormone helps researchers compare this new device to other proven forms of contraception. If the study is successful, it could pave the way for a practical, comfortable alternative to daily pills, giving women more choice and control over their sexual health.
Key takeaways
- Tests a new vaginal device releasing the contraceptive hormone levonorgestrel.
- Open to healthy adult women aged 18 and older.
- A Phase 1 study focused on measuring how the body absorbs the medicine over several days.
- Involves regular clinic visits and routine blood tests to track hormone levels.
- Participation is entirely voluntary, and you can withdraw whenever you wish.
Who may be eligible?
This study is looking for healthy female volunteers who are aged 18 and older. Because this is an early-stage study checking how a healthy body handles the medicine, participants should be in good general health with no major ongoing medical conditions.
You will likely not be able to take part if you are currently pregnant, planning to become pregnant during the trial, or breastfeeding. Women with conditions that could be affected by hormones, such as certain liver problems or a history of blood clots, will also be excluded for safety reasons.
The trial team will check what medications you currently take, including other forms of hormonal contraception, as these might interfere with the study results. A full health screening will take place before anyone is accepted into the study.
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 female aged 18 or older.
- I am in good general health with no chronic illnesses.
- I am not pregnant and not currently breastfeeding.
- I am comfortable using a vaginal device for a few days.
- I am able to visit the study clinic for scheduled blood tests.
What does participation involve?
Taking part will involve visiting a single specialist study clinic. Before the trial starts, you will have a screening visit to check your general health, which usually includes blood tests, urine tests, and a physical check-up. If you join, you will be shown how to insert and use the vaginal device for a set number of days. During the study, you will need to attend scheduled clinic visits where nurses will take regular blood samples to measure hormone levels in your body. You may also need to fill in a simple diary to record any symptoms or how comfortable the device felt. The trial team will track your health throughout, and there will be a final check-up after the device is removed to make sure you are well.
Potential risks and benefits
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Common questions
What is levonorgestrel?
Levonorgestrel is a widely used man-made hormone that acts like natural progesterone. It is commonly found in birth control pills and coils.
Will this device protect me from pregnancy during the study?
You should not rely on this device for birth control during the trial. The study team will advise you on what safe non-hormonal contraception you need to use while taking part.
Does inserting the vaginal device hurt?
Most vaginal devices are made of soft, flexible material similar to a menstrual cup or vaginal ring. Inserting it is generally painless, though some women may notice a mild, temporary feeling of pressure.
Will I be paid for taking part?
Phase 1 studies with healthy volunteers often provide compensation for your time, travel, and inconvenience. The study coordinator can give you exact details about this.
Can I leave the study early if I change my mind?
Yes. Taking part is completely voluntary. You can stop using the device and leave the trial at any point without giving an explanation.
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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