Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204074
Status:
UNKNOWN
Last Update Posted:
2005-12-29
First Post:
2005-09-12
Brief Title:
Treatment of Menstrual Migraine With Sequential Transdermal 17-Beta-Estradiol A Double-Blind Randomised Cross-Over Trial
Sponsor:
University Hospital Linkoeping
Organization:
University Hospital Linkoeping
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
During the fertile ages migraine is more common in women than in men 31 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 attackAbout 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 ie 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 womans 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 estradiolplacebo 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
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 womans 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 estradiolplacebo 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None