Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Investigate Drug-Drug Interactions between LVDS (Levonorgestrel Vaginal Delivery System) and Tampons and Lubricants in Healthy Female Participants

This research study is for healthy women and is about a new contraception method: a vaginal ring that slowly releases a hormone called levonorgestrel. The main goal is to check if using this vaginal ring at the same time as common products like tampons and lubricants changes how it works or how well the body absorbs the hormone. This is an early-stage study, meaning it's one of the first steps to understand how the new contraception behaves in the body. By understanding these interactions, scientists can make sure the vaginal ring is safe and effective for women to use in their daily lives, giving them more choices for family planning.

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 study is looking at a new type of contraception for women. It's a small, flexible ring that you place inside your vagina. This ring slowly releases a hormone called levonorgestrel, which helps to prevent pregnancy. Because it's a new product, scientists need to make sure that it works properly and safely when women are using other common products.

Specifically, this research wants to find out what happens when women use this new vaginal ring at the same time as tampons and lubricants. Many women use these products regularly, so it's really important to know if they affect how the contraceptive ring works. For example, could a tampon stop the ring from releasing enough hormone, or could a lubricant change how the body absorbs it?

The study will help us understand if there are any unexpected interactions. This information is key for doctors and women to know exactly how to use this new contraception safely and effectively if it becomes available in the future. By doing this research now, we can help ensure that new contraception options are as reliable and easy to use as possible.

Key takeaways

It's about a new type of female contraception (vaginal ring).
Looks at how it interacts with tampons and lubricants.
Aimed at healthy women aged 18 and over.
Helps ensure new contraception is safe and effective for daily use.
Early stage research, not for general patient use yet.

Who may be eligible?

This study is looking for healthy women aged 18 and over. There is no upper age limit, meaning women of any age above 18 can take part.

Because this study is focusing on normal use of contraception, you shouldn't have any specific medical conditions or serious ongoing illnesses. The researchers want to understand how the new vaginal ring works in generally healthy people.

The study is specifically for women, as it concerns a female contraceptive device. They will be looking for volunteers who meet these basic health requirements.

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 a woman?
Are you 18 years old or older?
Are you generally healthy?
Are you able to attend clinic visits regularly?

Answer every question to see your result.

What does participation involve?

In this study, you would receive the new levonorgestrel vaginal ring. You would also use tampons and lubricants as instructed by the study team. Researchers would regularly take blood samples to measure how much of the hormone from the ring is in your body and how it changes over time when you use it with tampons and lubricants. You would also have regular check-ups and answer questions about how you are feeling. The study involves several visits to the clinic and regular monitoring over a short period. The total duration of your involvement in the study will be explained in detail by the study team.

Potential risks and benefits

Potential benefits from taking part include contributing to important research that helps develop new contraception options for women. While there are no direct health benefits for you personally, your participation helps doctors understand how this new treatment works safely with other common products. Potential risks might include discomfort from inserting the vaginal ring, side effects from the hormone (though this is an early stage, and those will be monitored closely), or minor bruising/discomfort from blood draws. You are free 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.

—
Unverified
Portugal

Common questions

What is a vaginal ring?

It's a small, flexible ring inserted into the vagina that releases hormones to prevent pregnancy.

Why are you studying tampons and lubricants?

Researchers want to check if these common products change how the contraceptive ring works or how the body absorbs its hormone.

Will I get pregnant during the study?

The study focuses on the drug's interaction, not its contraceptive effectiveness in this phase. You will be given advice on contraception during the study.

What kind of treatments will I receive?

You will be given the new levonorgestrel vaginal ring and will use specific brands of tampons and lubricants as part of the study.

Is this contraception available now?

No, this is an early-stage research study, so the contraception is not yet available for general use.