Treatment of Menstrual Migraine With Sequential, Transdermal, 17-Beta-Estradiol. A Double-Blind, Randomised, Cross-Over Trial.
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|ClinicalTrials.gov Identifier: NCT00204074|
Recruitment Status : Unknown
Verified September 2005 by University Hospital, Linkoeping.
Recruitment status was: Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : December 29, 2005
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: 17-beta-estradiol (drug)||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Crossover Assignment|
|Study Start Date :||October 2001|
|Estimated Study Completion Date :||July 2005|
- Number of migraine attacks
- Severeity of migraine attacks
- Analgetics used
- Bleeding disturbances
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00204074
|Division of Obstetrics & Gynecology, Department of Molecular and Clinical Medicine, Faculty of Health Sciences|
|Linköping, Sweden, SE-58185|
|Principal Investigator:||Jan Brynhildsen||Department of Obstetrics & Gynecology, University Hospital, SE-58185, Linköping, Sweden|