Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Progesterone Vaginal Insert 100 mg in Healthy Pre-Menopausal, Nonpregnant Female Subjects.

This research study is for healthy women who are still having periods and are not pregnant. It's called a "bioequivalence" study, which means scientists want to check if a new 100mg progesterone medicine, given as a vaginal insert, is absorbed by the body in the same way as an existing progesterone medicine. This is an important step to make sure any new medication works just as well and safely as what's already available. Participants would be carefully monitored as part of this early stage of understanding how the medicine behaves in the body. It's not testing a new condition or treatment, but rather comparing how a new way of giving progesterone works.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Leon Farma S.A.

Enrolment target

Start

26 Sep 2023

No medical condition.

What is this study about?

This study is about a medicine called progesterone, which is often used in women's health for various reasons. In this study, researchers are looking at a specific way to give progesterone: a 100mg vaginal insert. They want to make sure that this new insert delivers progesterone to the body in a similar way to other progesterone medicines already on the market. Think of it like comparing two different brands of a common pain reliever – they both have the same active ingredient, but this study checks if your body uses them in roughly the same way.

This kind of study is called a 'bioequivalence' study. It's a really important step in drug development because it helps ensure that a new version of an existing medicine will be just as effective and safe. It's not about finding a new use for progesterone, but rather confirming that this particular formulation (the vaginal insert) works as expected.

The study involves healthy, pre-menopausal women. This means women who are still having their periods and are not pregnant. By studying healthy individuals, researchers can get a clear picture of how the body handles the medicine without other health conditions complicating the results. It's a foundational step to gather information for potential future use of this specific progesterone insert.

Key takeaways

This study is for healthy women still having periods.
It's testing a 100mg progesterone vaginal insert.
The goal is to understand how the body absorbs this medicine.
It helps ensure the new insert works like existing progesterone medicines.
Participation involves clinic visits and likely blood tests.
You won't be treated for a specific medical condition.

Who may be eligible?

This study is specifically looking for women who are healthy and still having their monthly periods. You should not be pregnant to take part.

To be eligible, you need to be at least 18 years old. There is no upper age limit, as long as you are still in your pre-menopausal years (meaning you haven't gone through menopause yet).

Since this is an early-stage study testing how your body handles the medicine, it's really important that you don't have any serious health problems that might affect the results.

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?
Are you at least 18 years old?
Do you still have your monthly periods (pre-menopausal)?
Are you currently not pregnant?
Are you generally in good health with no major medical conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the 100mg progesterone vaginal insert. The study is designed to track how your body absorbs and processes this medication. This will likely involve a few visits to a clinic over a set period. During these visits, you might have blood samples taken to measure the levels of progesterone in your body. There could also be other routine health checks to make sure you remain well throughout the study. The exact number of visits, tests, and the total length of your involvement would be explained in full detail by the study team, but these types of studies generally involve close monitoring for a relatively short period.

Potential risks and benefits

Taking part in a study like this might not directly benefit your health, as it's an early-stage study focused on understanding the medicine. However, you would be contributing important information that could help others in the future. Potential risks are generally low in bioequivalence studies but could include mild side effects from the medication or discomfort from blood tests. All known risks would be fully explained before you agree to participate. You always have the right 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
Portugal

Common questions

What does 'pre-menopausal' mean?

It means you are still having your regular monthly periods and haven't gone through menopause yet.

Why are only healthy women being included?

Researchers want to see how the medicine works in a typical, healthy body without other health issues that might change the results.

What is progesterone used for normally?

Progesterone is a hormone that plays a key role in the menstrual cycle, pregnancy, and fertility treatments, among other things.

Will I be given a new medicine I haven't heard of?

No, progesterone itself is a well-known hormone. This study is just testing a new way of giving a specific dose (100mg) as a vaginal insert.

How long does the study last?

The exact duration will be explained by the study team, but these types of studies typically involve a period of close monitoring lasting a few days to a few weeks.