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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
Sponsor:
Information provided by:
University Hospital, Linkoeping

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.

Condition or disease Intervention/treatment Phase
Migraine Drug: 17-beta-estradiol (drug) Phase 2 Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : October 2001
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources




Primary Outcome Measures :
  1. Number of migraine attacks
  2. Severeity of migraine attacks
  3. Analgetics used

Secondary Outcome Measures :
  1. Bleeding disturbances


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
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

Information from the National Library of Medicine

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


Locations
Sweden
Division of Obstetrics & Gynecology, Department of Molecular and Clinical Medicine, Faculty of Health Sciences
Linköping, Sweden, SE-58185
Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
Principal Investigator: Jan Brynhildsen Department of Obstetrics & Gynecology, University Hospital, SE-58185, Linköping, Sweden

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00204074     History of Changes
Other Study ID Numbers: Mensmig1
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 29, 2005
Last Verified: September 2005

Keywords provided by University Hospital, Linkoeping:
Migraine
Menstrual cycle
17 beta-estradiol
Transdermal administration

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female