Migraine Clinical Trial
The purpose of this study is to determine whether transdermally administered 17-beta estradiol sequentially could reduce the number of, and severity of, menstrual migraine attacks.
During the fertile ages, migraine is more common in women than in men (3:1). Hormonal
factors has been proposed to affect this difference and it has been shown that a rapid
decrease in serum concentrations of estrogens might trigger an attack.About 15 percent of
all women with migraine suffer from menstrual migraine which means that the attacks only
come during the menstrual period and start +/- 24 hours of the bleeding start, i.e when
there is a rapid decrease in serum concentrations of sex hormones.
Stabilizing the serum concentrations of estrogens seems to be crucial in the prophylactic
treatment of menstrual migraine. A number of studies have focused on treatment with
estradiol during the menstrual cycle but results are conflicting and doses and control
groups have varied a lot. other studies have tried to reduce the exposition of estrogens by
treatment with, for example, GnRH analogues. This treatment stabilizes the woman's serum
concentrations of sex hormones on a very low level, like during the menopause, and it seems
to be effective but there are a number of side-effects and the treatment is expensive.
Comparison: In a double-blind, randomized cross-over trial women with strictly defined
menstrual migraine will receive treatment with 100 microg 17-beta estradiol/placebo
transdermally one week before the estimated start of the menstrual bleeding and twoo weeks
on. After three cycles and a wash-out period the treatment will be repeated but now with the
tratment the woman did not have during the first treatment period. The women serve as their
own controls.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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