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Treatment of Menstrual Migraine With Sequential, Transdermal, 17-Beta-Estradiol. A Double-Blind, Randomised, Cross-Over Trial.
This study is ongoing, but not recruiting participants.
First Received: September 12, 2005   Last Updated: December 28, 2005   History of Changes
Sponsor: University Hospital, Linkoeping
Information provided by: University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT00204074
  Purpose

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 Intervention Phase
Migraine
Drug: 17-beta-estradiol (drug)
Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • Number of migraine attacks
  • Severeity of migraine attacks
  • Analgetics used

Secondary Outcome Measures:
  • Bleeding disturbances

Study Start Date: October 2001
Estimated Study Completion Date: July 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Study ID Numbers: Mensmig1
Study First Received: September 12, 2005
Last Updated: December 28, 2005
ClinicalTrials.gov Identifier: NCT00204074     History of Changes
Health Authority: Sweden: Medical Products Agency

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

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

ClinicalTrials.gov processed this record on November 25, 2009