- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00204074
Treatment of Menstrual Migraine With Sequential, Transdermal, 17-Beta-Estradiol. A Double-Blind, Randomised, Cross-Over Trial.
Study Overview
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
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Linköping, Sweden, SE-58185
- Division of Obstetrics & Gynecology, Department of Molecular and Clinical Medicine, Faculty of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Number of migraine attacks
|
Severeity of migraine attacks
|
Analgetics used
|
Secondary Outcome Measures
Outcome Measure |
---|
Bleeding disturbances
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jan Brynhildsen, Department of Obstetrics & Gynecology, University Hospital, SE-58185, Linköping, Sweden
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Estradiol
- Estradiol 17 beta-cypionate
- Estradiol 3-benzoate
- Polyestradiol phosphate
Other Study ID Numbers
- Mensmig1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Migraine
-
Austrian Migraine Registry CollaborationMedical University of Vienna; Medical University Innsbruck; Austrian Headache...RecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineAustria
-
Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
-
Harvard University Faculty of MedicineBrigham and Women's Hospital; Palmer Center for Chiropractic Research (PCCR)CompletedMigraine | Migraine Disorders | Migraine Without Aura | Migraine With Aura | Migraine, ClassicUnited States
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
CoolTech LLCTerminatedMigraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineUnited States
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
Notre-Dame Hospital, Montreal, Quebec, CanadaAllerganCompletedChronic Migraine | Migraine Without Aura | Migraine With AuraCanada
-
Glostrup University Hospital, CopenhagenUnknownChronic Migraine | Migraine Without Aura | Migraine With AuraDenmark
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...CompletedMigraine With Aura | Migraine in ChildrenItaly
-
The Cleveland ClinicWithdrawnMigraine | Migraine Disorders | Headache Disorders, Primary | Migraine Headache | Migraine Without Aura | Migraine With Aura | Headache, MigraineUnited States
Clinical Trials on 17-beta-estradiol (drug)
-
Assistance Publique - Hôpitaux de ParisSolvay Pharmaceuticals; French Health Products Safety Agency; FRMTerminatedHealthy Symptomatic Menopausal WomenFrance
-
University of HelsinkiPäivikki and Sakari Sohlberg Foundation, Finland; Finnish Medical Foundation; Emil Aaltonen FoundationCompletedCardiovascular Disease | Postmenopausal Vasomotor SymptomsFinland
-
Novo Nordisk A/SCompletedTurner Syndrome | Genetic DisorderSpain
-
Nemours Children's ClinicEli Lilly and CompanyCompletedHypogonadism | Turner Syndrome | Premature Ovarian FailureUnited States
-
Nemours Children's ClinicGenentech, Inc.CompletedHypogonadism | Turner Syndrome | Premature Ovarian FailureUnited States, Chile
-
One FertilityUnknown
-
Maple Leaf ResearchRecruiting
-
Indira IVF Hospital Pvt LtdTerminatedInfertility, Female | Frozen Embryo TransferIndia
-
Yale UniversityNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
Boehringer IngelheimWithdrawnLeukemia, Lymphocytic, Chronic, B-Cell