Treatment of Menstrual Migraine With Sequential, Transdermal, 17-Beta-Estradiol. A Double-Blind, Randomised, Cross-Over Trial.
Primary Purpose
Migraine
Status
Unknown status
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
17-beta-estradiol (drug)
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring Migraine, Menstrual cycle, 17 beta-estradiol, Transdermal administration
Eligibility Criteria
Inclusion Criteria: Migraine only during the menstrual period Migraine attacks each menstrual period during the last year Regular menstrual cycle Exclusion Criteria: Migraine other times than during the menstrual period Use of hormonal contraceptives (other than depo-provera)during the last three months. Depo-provera injection the last year History of Thrombo-embolism Liver disease History of malignancy Breast-feeding during the last two months Abortion/miscarriage during the last two months Pregnancy
Sites / Locations
- Division of Obstetrics & Gynecology, Department of Molecular and Clinical Medicine, Faculty of Health Sciences
Outcomes
Primary Outcome Measures
Number of migraine attacks
Severeity of migraine attacks
Analgetics used
Secondary Outcome Measures
Bleeding disturbances
Full Information
NCT ID
NCT00204074
First Posted
September 12, 2005
Last Updated
December 28, 2005
Sponsor
University Hospital, Linkoeping
1. Study Identification
Unique Protocol Identification Number
NCT00204074
Brief Title
Treatment of Menstrual Migraine With Sequential, Transdermal, 17-Beta-Estradiol. A Double-Blind, Randomised, Cross-Over Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Linkoeping
4. Oversight
5. Study Description
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 (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Menstrual cycle, 17 beta-estradiol, Transdermal administration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
17-beta-estradiol (drug)
Primary Outcome Measure Information:
Title
Number of migraine attacks
Title
Severeity of migraine attacks
Title
Analgetics used
Secondary Outcome Measure Information:
Title
Bleeding disturbances
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Eligibility Criteria
Inclusion Criteria:
Migraine only during the menstrual period
Migraine attacks each menstrual period during the last year
Regular menstrual cycle
Exclusion Criteria:
Migraine other times than during the menstrual period
Use of hormonal contraceptives (other than depo-provera)during the last three months.
Depo-provera injection the last year
History of Thrombo-embolism
Liver disease
History of malignancy
Breast-feeding during the last two months
Abortion/miscarriage during the last two months
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Brynhildsen
Organizational Affiliation
Department of Obstetrics & Gynecology, University Hospital, SE-58185, Linköping, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Obstetrics & Gynecology, Department of Molecular and Clinical Medicine, Faculty of Health Sciences
City
Linköping
ZIP/Postal Code
SE-58185
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
21704313
Citation
Almen-Christensson A, Hammar M, Lindh-Astrand L, Landtblom AM, Brynhildsen J. Prevention of menstrual migraine with perimenstrual transdermal 17-beta-estradiol: a randomized, placebo-controlled, double-blind crossover study. Fertil Steril. 2011 Aug;96(2):498-500.e1. doi: 10.1016/j.fertnstert.2011.05.089. Epub 2011 Jun 24.
Results Reference
derived
Learn more about this trial
Treatment of Menstrual Migraine With Sequential, Transdermal, 17-Beta-Estradiol. A Double-Blind, Randomised, Cross-Over Trial.
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