Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A multicentre, single arm trial on contraceptive efficacy, safety and tolerability of LVDS (Levonorgestrel Vaginal Delivery System) during 13 cycles.

This study is looking at a new type of contraception called a Levonorgestrel Vaginal Delivery System (LVDS) – it's a vaginal ring that releases a hormone. The main goal is to find out how effective it is at preventing pregnancy in women aged 18 to 35 who are not breastfeeding. Researchers will follow these women for 13 monthly cycles (about a year and a month). They will also be carefully checking for any side effects, how easy it is to use, and how it affects things like bleeding patterns. This is a large-scale study, which means it’s one of the final steps before a new medicine or device can be considered for wider use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Chemo Research S.L.

Enrolment target

1,037

Start

12 Jul 2023

Prevention of pregnancy

What is this study about?

Imagine a new way to prevent pregnancy – a soft, flexible ring that you place inside your vagina. This ring slowly releases a hormone to stop you from getting pregnant. This study is testing one such ring, called the Levonorgestrel Vaginal Delivery System (LVDS).

The main purpose of this study is to see how well this new vaginal ring works as contraception. The researchers want to find out how many women using this ring will get pregnant over a 13-month period. They are particularly interested in women between the ages of 18 and 35 who are not breastfeeding. This information is key to understanding if the ring is a reliable option for birth control.

But it's not just about stopping pregnancy. The study will also keep a close eye on safety. This means researchers will check for any side effects or uncomfortable symptoms from using the ring. They'll also look at how easy or comfortable it is for women to use and whether it affects their periods or general health. This type of study is a crucial step to make sure any new contraceptive method is both effective and safe for people to use.

Key takeaways

Tests a new vaginal ring for contraception.
Aims to see how well it prevents pregnancy.
Will check for safety and side effects.
Participants will use the ring for 13 months.
Open to women aged 18 and over, who are not breastfeeding.

Who may be eligible?

This study is specifically looking for women to take part. You must be at least 18 years old to be considered.

There isn't an upper age limit mentioned, but the main focus of the study is on women between 18 and 35 years old. You also cannot be breastfeeding if you wish to participate.

Additional health requirements, which are common in all clinical trials, would be discussed with you by the study team. These might include your general health, any existing medical conditions, or medications you are currently taking.

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 not currently breastfeeding?
Are you able to commit to 13 months of study participation?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be using the Levonorgestrel Vaginal Delivery System (LVDS) – the new contraceptive vaginal ring – for 13 consecutive monthly cycles, which is just over a year. The study team would teach you how to use it. You would have regular visits to the study clinic to check your health, discuss any experiences with the ring, and make sure everything is going well. These visits would involve general health checks, physical examinations, and possibly some gynaecological check-ups. The total duration of the study for each participant would be approximately 13 months.

Potential risks and benefits

Participating in this study might offer you access to a new contraceptive method before it's widely available. You'll receive regular health checks and close medical supervision. However, as with any medication, there's a chance you might experience side effects, and the contraception might not be 100% effective, meaning there's a small risk of pregnancy. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
Hungary
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Unverified
Czechia
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Unverified
Poland
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Unverified
Spain
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Unverified
Lithuania
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Unverified
Slovakia
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Unverified
Romania

Common questions

What is a 'vaginal delivery system'?

It's a soft, flexible ring that you place inside your vagina, and it slowly releases medicine into your body.

What does 'non-breastfeeding women' mean?

It means the study is for women who are not currently breastfeeding a baby.

What is 'contraceptive efficacy'?

This refers to how well the contraception works to prevent pregnancy.

What is a 'Pearl Index'?

It's a way of measuring how effective a contraceptive method is. A lower number means it's more effective.

How long will I be in the study?

You will be in the study for 13 monthly cycles, which is about one year and one month.