AuthorisedPhase III and phase IV (Integrated)Interventional

(WHAT!) – RCT: Open-label randomized controlled trial for the effects of continuous daily use of ethinylestradiol/levonorgestrel (30/150 µg/day) compared with vitamin E (400 IU/day) in the treatment of menstrually-related migraine and perimenopausal migraine

This research is a study comparing two different treatments for women who suffer from migraines connected to their menstrual cycle or during perimenopause (the time leading up to menopause). One treatment is a daily hormone pill, similar to Microgynon 30, which contains ethinylestradiol and levonorgestrel. The other treatment being tested is a daily vitamin E supplement (400 IU). The main goal is to find out if either of these treatments can help reduce the number of migraine days a woman experiences over a 28-day period, as measured after 12 weeks. The study also looks at how these treatments affect the total number of headache days and how many women have a big reduction in their migraines.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Leids Universitair Medisch Centrum (LUMC)

Enrolment target

360

Start

29 Nov 2024

Migraine

What is this study about?

This study is for women who get migraines, especially those linked to their monthly period or the time around menopause (known as perimenopause). Migraines can be very disruptive, causing intense headaches, sickness, and sensitivity to light and sound. Finding effective treatments for these specific types of migraines is very important to improve women's quality of life.

The researchers want to compare two different approaches. One is a type of daily hormone pill, similar to a combined oral contraceptive like Microgynon 30. This pill contains two hormones, ethinylestradiol and levonorgestrel. The other approach is taking a daily vitamin E supplement (400 IU).

The main aim is to see if either of these treatments can help reduce how many days a month women experience migraines. They will track this over 12 weeks. They will also look at other things, like the total number of headache days and how many women have a significant improvement, meaning at least a 50% cut in their migraine days. By comparing these two treatments, the study hopes to discover which might be more helpful for managing these specific migraines.

Key takeaways

Compares a hormone pill (like Microgynon 30) with vitamin E for migraines.
For women with period-related or perimenopausal migraines.
Aims to reduce monthly migraine days over 12 weeks.
Participation involves taking a daily treatment and tracking migraines.
Both you and the doctors will know which treatment you get.

Who may be eligible?

This study is specifically looking for women aged 18 and over. It's designed for people who experience migraines that are related to their menstrual cycle – meaning they often happen around their period – or during the perimenopausal stage, which is the time leading up to menopause.

To be considered for this study, your doctor will need to confirm your diagnosis of these specific types of migraines. It's important that you are a woman and are at least 18 years old.

There might be other health conditions or medications that could prevent you from taking part, but the main criteria are being an adult woman with menstrually-related or perimenopausal migraines.

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 18 years old or older?
Do you get migraines that are linked to your menstrual period?
Do you get migraines that happen during the time leading up to menopause (perimenopause)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to receive either a daily hormone pill (like Microgynon 30) or a daily vitamin E supplement for 12 weeks. Being 'randomly assigned' means you won't get to choose which treatment you receive, as it's decided by chance, like flipping a coin. You will need to keep a diary or record of your migraine days and other headache symptoms throughout the study. There will likely be regular check-ups or visits with the study team to monitor your progress and ensure your safety. The main assessment of your migraine days will happen between weeks 9 and 12 of the study. The total duration of your active involvement in the study, including treatment and assessments, will be 12 weeks.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as receiving a treatment that might reduce your migraine frequency or severity, and close medical monitoring. However, there are also potential risks; for example, the treatments might not work for you, or you could experience side effects. Hormone pills, in particular, have known side effects. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual 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 specifically is a 'menstrually-related migraine'?

This is a migraine that often happens around the time of your period, either just before, during, or shortly after it starts.

What does 'perimenopausal migraine' mean?

This refers to migraines that develop or change in pattern during the perimenopause, which is the natural transition period leading up to menopause.

Will I know if I'm taking the hormone pill or vitamin E?

Because this study is 'open-label', both you and the study team will know which treatment you are receiving.

How long will I be involved in the study?

Your active participation, including getting your treatment and being assessed, will last for 12 weeks.

What is the main thing the study wants to find out?

The study's main goal is to see if either treatment can reduce the number of migraine days you have each month after 12 weeks.