There are too many issues. One is safety, and one is if they are effective to treat migraine. Referring to safety, I want to say that there are some misbeliefs, mostly related to older studies. Those older studies provided the data about an increased risk of ischemic stroke in women who were users of combined hormonal contraceptives. But it’s important to note that in those studies women used very high estrogens dose, more than 50 micrograms per day...
There are too many issues. One is safety, and one is if they are effective to treat migraine. Referring to safety, I want to say that there are some misbeliefs, mostly related to older studies. Those older studies provided the data about an increased risk of ischemic stroke in women who were users of combined hormonal contraceptives. But it’s important to note that in those studies women used very high estrogens dose, more than 50 micrograms per day. And now we know that those type of estrogens are not safe, but not only in women with migraine overall. And for this reason, those have not [inaudible] in the market. And now we use estrogens with much lower concentration. And regarding the dose type of estrogens with the low and the very low, 10, 15 micrograms of estrogen, there are no high-quality data which can really address if they carry a higher risk of stroke in women with migraine.
And so, since we have no good evidence that they are harmful, there are no overall reasons to avoid them. The only exception I want to say is, women with migraine with aura because here we know that migraine with aura is an independent risk factor of ischemic stroke, even in women who are not users of combined hormonal contraceptives. And here there’s some evidence which suggests that the user of the estrogens may magnify this risk. And so, considering those points in women with migraine with aura, the use of estrogen is not suggested for the contraceptive reasons, where you have also different options. It may be used for medical reasons, so for example, women who have polycystic ovary or endometriosis. At [inaudible ] women with migraine without aura that have no concerns and there’s suggestions which favor of the use of estrogens if they are needed for the contraception or the medical reasons. And the other part of the question that relates to treatment or migraine with the estrogens, as I told before, the migraine occurrence during menstruation is related to an estrogen drop. And by giving estrogen supplementation, or even better, the continuous administration of hormones, you can avoid the estrogen drop. It can improve the migraine occurrence associated with menstruation.