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EHC 2022 | WHAT! trial of hormonal treatment for menstrual migraine

Small studies have suggested a beneficial effect of hormonal contraceptives for the treatment of migraine in women. Still, there needs to be more evidence as no large randomized controlled trials have been performed. Gisela Terwindt, MD, PhD, Leiden University, Leiden, Netherlands, discusses the WHAT! trial (NCT04007874) aiming to investigate the superiority of continuous oral contraceptive treatment (ethinylestradiol/levonorgestrel) for menstrual migraine compared to vitamin E, which has shown a beneficial effect in a small study. This interview took place at the 16th European Headache Congress (EHC) in Vienna, Austria.

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Transcript (edited for clarity)

So the WHAT! trial is the Women Hormones Attacks and Treatment trial. It’s performed by our group at Leiden University Medical Center in close collaboration with Erasmus MC. And we are doing these kind of studies because there is not much attention about the female-specific features that play a role in migraine. So we started very thoroughly with this WHAT! trial and WHAT studies first by looking at what’s the definition of menstrual-related migraine, and can women actually assess and do they know whether they have menstrual-related attacks?

Well it turned out that many women cannot state clearly whether they have menstrual-related attacks...

So the WHAT! trial is the Women Hormones Attacks and Treatment trial. It’s performed by our group at Leiden University Medical Center in close collaboration with Erasmus MC. And we are doing these kind of studies because there is not much attention about the female-specific features that play a role in migraine. So we started very thoroughly with this WHAT! trial and WHAT studies first by looking at what’s the definition of menstrual-related migraine, and can women actually assess and do they know whether they have menstrual-related attacks?

Well it turned out that many women cannot state clearly whether they have menstrual-related attacks. So you really need e-diary tools to assess menstrual-related migraines. So that’s what we started with. We also show that menstrual-related attacks are of longer duration, are more severe, and it’s more likely that there will be a recurrence after the intake of triptan. So that’s for the acute treatment. And now we are currently doing a very important study where we look at the preventive effect of the oral contraceptive pill in young women because many family doctors and neurologists and gynecologists, they prescribe oral contraceptives for treatment of migraine, but there is no proof whether it actually works. And also for those with migraine with aura, it might increase the risk for cerebral vascular events.

So we think taking hormonal treatment is not taking just a candy, it’s a real medicine and we need to prove whether it’s actually effective or not. So we have a very practical trial now in our country running where we ask young people to get involved in our study where we compare the oral contraceptive pill with vitamin E, as there have been some proof that vitamin E would be effect on the hormonal status as well, but our hypothesis is that oral contraceptive pill will work much better than vitamin E for these young women with migraine.

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