Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Investigation of Drug-Drug Interactions between LVDS (Levonorgestrel Vaginal Delivery System) and Miconazole in Healthy Female Participants.

This study is exploring how a special vaginal ring that releases a hormone (called LVDS) might interact with a common anti-fungal cream (miconazole). Specifically, researchers want to see if using both at the same time changes how the body handles either the hormone or the anti-fungal cream. This is important information to ensure that future treatments are safe and work as expected when people might be using more than one medicine. This type of study is done in healthy women to get a clear picture of how these substances behave in the body without other health conditions getting in the way.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Chemo Research S.L.

Enrolment target

Start

08 May 2025

No medical condition.

What is this study about?

This research study is about understanding how two different medical products might affect each other when used at the same time. One product is a special ring that is put into the vagina and slowly releases a hormone called levonorgestrel (we're calling it LVDS for short). The other product is miconazole, a common cream used to treat fungal infections, like thrush.

The main goal is to see if using the LVDS ring and miconazole cream together changes how your body handles either the hormone from the ring or the miconazole. For example, does using the cream make your body absorb more or less of the hormone? Or does the ring change how long the miconazole stays in your system? This is really important because if medicines interact, it could make one less effective or cause unexpected side effects.

By carefully studying these interactions in healthy volunteers, scientists can gather important information. This helps ensure that when doctors prescribe these treatments in the future, they know if there are any special instructions or warnings needed when patients might be using both. It's all about making sure medicines are as safe and effective as possible for everyone.

Key takeaways

This study investigates how a vaginal hormone ring and an anti-fungal cream interact.
It aims to ensure these treatments are safe and effective when used together.
Only healthy women, aged 18 and over, can participate.
Participants will receive both study products and have regular health checks.
Understanding drug interactions is crucial for future medical care.

Who may be eligible?

This study is specifically looking for healthy women to take part. This means you shouldn't have any ongoing medical conditions that need treatment, as the study wants to see how the medicines work without other health issues getting in the way.

You need to be 18 years old or older to join this study. If you are a woman and meet this age requirement, the study may be a possibility for you. There is no upper age limit, meaning women of any adult age can be considered.

Since this study involves products used in the vagina, participants must be biologically female. The researchers want to understand how these particular treatments work in women's bodies.

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.
I am 18 years old or older.
I generally consider myself to be in good health.
I do not have any ongoing medical conditions that need regular treatment.

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will be given the levonorgestrel vaginal ring (LVDS) and miconazole at different times. The study will involve several visits to a clinic where doctors and nurses will monitor you closely. They will take blood and urine samples to check how your body is processing the medicines. You might also have other assessments to check your health throughout the study. The total duration of your involvement, including all visits and follow-up, will be explained in detail by the study team. You'll need to be available for all scheduled appointments.

Potential risks and benefits

Taking part in this study could help us learn important information about how medicines interact, benefiting future patients. However, there are some potential risks, such as discomfort from blood draws, or potential side effects from the study medications, which will be fully explained to you. You 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 is levonorgestrel LVDS?

LVDS stands for Levonorgestrel Vaginal Delivery System. It's a special ring placed in the vagina that slowly releases a hormone called levonorgestrel.

What is miconazole?

Miconazole is a common cream used to treat fungal infections, for example, thrush.

Why is this study only for healthy women?

The study needs to understand how the medicines work in healthy people first, without other health conditions making it complicated.

Will I get paid for taking part?

The study team will tell you if any expenses, like travel, will be covered or if there's any payment for your time. This information will be in the patient information sheet.

Is this a new medicine?

The study is looking at how existing medicines work together, rather than testing a brand new, unknown medicine.