Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

WOMEN&More: Prospective phase III multi-center open-label study of the efficacy, safety, and acceptability of mifepristone 50 mg once-weekly as a contraceptive

The WOMEN&More study is investigating a new tablet designed to prevent pregnancy, taken once a week. It aims to confirm how effective a 50mg dose of mifepristone is at preventing pregnancy in real-world use, including both when the pill is used perfectly and when mistakes happen. Researchers will also closely monitor its safety, looking at potential side effects, especially concerning liver function and changes to the womb lining. An important part of the study is understanding if women find this new contraceptive acceptable and convenient to use. The ultimate goal is to see if this weekly pill could offer a good new option for contraception for women.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Leiden University Medical Center

Enrolment target

1,186

Start

28 Feb 2025

Contraception

What is this study about?

The WOMEN&More study is looking into a new way to prevent pregnancy using a medication called mifepristone. This study is designed to see if a 50mg dose of mifepristone, taken once a week, can be an effective and safe birth control option. "Therapeutic confirmatory" means it's a big study to make sure the treatment works and is safe before it might be made widely available.

The main thing the researchers want to find out is how many women get pregnant while using this pill. This includes pregnancies that happen if someone forgets to take the pill (user failure) as well as those that might happen even when the pill is taken correctly (method failure). They’ll also be carefully checking for any side effects, like changes to the womb’s lining (endometrial thickness) or liver health, and how acceptable the pill is for women to use in their daily lives.

This study is important because it could lead to a new contraceptive choice for women. Having more options means women can find the method that best suits their lifestyle and health needs. By checking how well it works and if it's safe, and by understanding women's experiences with it, this research aims to provide valuable information about a potential new weekly birth control pill.

Key takeaways

This study is testing a new weekly contraceptive pill.
It aims to find out how well it prevents pregnancy (Pearl Index).
Researchers will also check for safety, including effects on the womb and liver.
The study wants to see how acceptable and convenient the pill is for women.
Participants will have regular health check-ups and monitoring.

Who may be eligible?

This study is looking for women who are at least 18 years old. There's no upper age limit, meaning women of any adult age can potentially take part if they meet other health requirements.

The study is specifically for women who need contraception. This means you would be looking for a way to prevent pregnancy and would be willing to use the study medication for that purpose.

Medical staff will check your health to make sure this study is right for you and that taking the study medication would be safe. They'll ask about your health history and current medications to make sure you fit the study's specific 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 able to get pregnant?
Are you at least 18 years old?
Are you looking for a new method of contraception?
Are you willing to take a tablet once a week?
Are you able to attend regular clinic visits for check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given the study medication, mifepristone 50mg, to take once a week. You would have regular check-ups with the study team. These visits would involve taking pregnancy tests, having blood tests to check your liver function, and having ultrasound scans to look at the lining of your womb.

The study team will also ask you questions about your general health, any side effects you might experience, your mood, sexual health, any changes in your weight, and your bleeding patterns. They'll want to understand how you feel about using the medication and if it fits into your life easily. If a pregnancy occurs during the study, they will also record the outcome.

Potential risks and benefits

Taking part in this study may offer the potential benefit of a new, convenient, once-weekly form of contraception. You would also receive regular medical check-ups and monitoring. However, there are potential risks, including the possibility of pregnancy despite using the study medication, and potential side effects such as changes to your womb lining or liver function. All potential risks will be thoroughly explained to you, and 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
Netherlands

Common questions

What is mifepristone?

Mifepristone is a medication being tested in this study to see if it can safely and effectively prevent pregnancy when taken once a week.

What does 'once-weekly' mean?

It means you would take one tablet of the study medication, mifepristone 50mg, just once every seven days.

What is a 'Pearl Index'?

The Pearl Index is a way for researchers to measure how many pregnancies happen per 100 women using a certain birth control method for one year. A lower number means it's more effective.

Will I have regular check-ups?

Yes, if you join the study, you'll have regular appointments to monitor your health, check for side effects, and make sure the medication is working for you.

What if I get pregnant during the study?

The study team will record any pregnancies that occur and their outcomes, as this helps them understand the effectiveness of the medication. You will be supported by the medical team.