Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A mono-centre, non-comparative clinical trial on the inhibition of ovulation with LNG POP (Levonorgestrel tablet, 0.135 mg) during three 28-day cycles with continuous treatment and intentional intake errors

This study is investigating a specific type of daily contraceptive pill that contains a hormone called levonorgestrel (also known as a mini-pill). The main goal is to understand how effectively this pill prevents a woman's body from releasing an egg (ovulation). Researchers are particularly interested in seeing how well it works even if a dose is intentionally missed. This helps them understand how the pill performs in everyday situations where people might forget to take it. The study will last for three cycles (about three months) and involve women taking the pill continuously. This research is in an early stage (Phase II) and aims to gather more information about this contraceptive method.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

SocraTec R&D Concepts in Drug Research and Development GmbH

Enrolment target

Start

05 Jun 2025

Investigation of ovulation inhibition after intentional IMP intake errors for indication of contraception

What is this study about?

This study is all about a specific type of daily birth control pill, often called a "mini-pill." This pill contains a single hormone called levonorgestrel (0.135 mg). The main thing the researchers want to find out is how well this pill stops a woman's body from releasing an egg each month, which is called ovulation. Preventing ovulation is how many birth control pills work to stop pregnancy.

What makes this study a bit different is that the researchers will be asking participants to intentionally miss taking their pill a few times during the study. This isn't usually what happens in real life, but it helps the scientists understand the pill's limits. By doing this, they can get a better idea of how forgiving the pill is if someone forgets to take it exactly on time, which can happen in day-to-day life. This information is really important for doctors and women when choosing the best contraception for them.

The study is planned to run for three regular monthly cycles, which is about three months in total. During this time, participants will take the levonorgestrel pill every day. This research is considered an early-stage study (Phase II), meaning they are still gathering basic information to understand how the treatment works. The aim is to make sure that contraception options for women are as effective and easy to use as possible.

Key takeaways

This study is about a daily birth control pill (levonorgestrel).
It aims to understand how well the pill prevents ovulation (releasing an egg).
Researchers will study what happens when doses are intentionally missed.
The study lasts for about three months.
It's for women aged 18 and over.
This research helps improve our knowledge of contraception.

Who may be eligible?

This study is specifically looking for women to take part. To be considered, you need to be at least 18 years old. There isn't an upper age limit mentioned, so women of all adult ages could potentially participate.

Because the study is about preventing pregnancy, it's important that you are able to become pregnant and are not currently pregnant or breastfeeding. You would also need to be generally healthy and able to follow the study instructions carefully.

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?
Are you able to become pregnant?
Are you generally in good health?
Are you willing and able to take a daily pill for about three months?
Are you able to attend regular appointments at the study centre?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be taking a levonorgestrel pill (0.135 mg) every day for three menstrual cycles, which is roughly three months. During this time, you will have several visits to the study centre, where doctors and nurses will monitor your health and how the pill is affecting you. They will do this by taking blood samples to check hormone levels, and possibly perform ultrasounds to see if your body is trying to release an egg. You will also be asked to intentionally miss a few doses of your pill at specific times, under controlled conditions, to help the researchers understand its effectiveness. The total length of your time in the study, including all visits and taking the medication, will be about three months.

Potential risks and benefits

Potential benefits of taking part include contributing to a better understanding of contraceptive pills, which could help future women make informed choices. You would also receive regular health monitoring. Potential risks might include side effects from the levonorgestrel pill, which are generally mild but can include irregular bleeding, headaches, or mood changes. There is also a very small chance of unintended pregnancy, especially when doses are intentionally missed. 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
Germany

Common questions

What is levonorgestrel 0.135 mg?

It's a type of hormone found in some daily birth control pills, often called a 'mini-pill'. It helps prevent pregnancy.

What does 'inhibition of ovulation' mean?

It means stopping your body from releasing an egg each month. If an egg isn't released, you can't get pregnant.

Why would I intentionally miss a pill?

Researchers want to see how well the pill works even if a dose is forgotten. This helps them understand its real-world effectiveness.

How long will the study last if I join?

The study will last for three menstrual cycles, which is typically about three months.

Will I be protected from pregnancy during the study?

While the pill is designed to prevent pregnancy, especially with the intentional missed doses, there is a small chance of pregnancy. The study team will discuss this fully with you.