MigrainePhase 2/3NCT00204074
Treatment of Menstrual Migraine With Sequential, Transdermal, 17-Beta-Estradiol. A Double-Blind, Randomised, Cross-Over Trial.
A Phase 2/3 study testing 17-beta-estradiol (drug) in people with Migraine, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Migraine
- What is being tested?
- 17-beta-estradiol (drug)
- How many people
- Not given
- Where
- 1 siteSweden
- Study dates
- Oct 2001to Jul 2005
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
Who may be able to join
- Migraine only during the menstrual period
- Migraine attacks each menstrual period during the last year
- Regular menstrual cycle
Who cannot join
- 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
Show all 9Show fewer
- Breast-feeding during the last two months
- Abortion/miscarriage during the last two months
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Division of Obstetrics & Gynecology, Department of Molecular and Clinical Medicine, Faculty of Health Sciences
Linköping, SE-58185
About this study
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.
Read the 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.
- Conditions
- Migraine
- Being tested
- 17-beta-estradiol (drug)
- Keywords
- Migraine, Menstrual cycle, 17 beta-estradiol, Transdermal administration
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17-beta-estradiol (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of migraine attacks
Severeity of migraine attacks
Analgetics used
Secondary outcomes (1)
Bleeding disturbances
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2001
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Investigators
- Jan Brynhildsen, Principal investigator, Department of Obstetrics & Gynecology, University Hospital, SE-58185, Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204074
- Sponsor's protocol ID
- Mensmig1
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 29 Dec 2005
- Results posted
- No
Publications
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.
PubMed 21704313
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Menstrual Migraine With Sequential, Transdermal, 17-Beta-Estradiol. A Double-Blind, Randomised, Cross-Over Trial.
- ClinicalTrials.gov ID
- NCT00204074
- Acronym / sponsor ID
- Mensmig1
- Conditions
- Migraine
- Keywords
- Migraine, Menstrual cycle, 17 beta-estradiol, Transdermal administration
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Oct 2001
- Study completion
- Jul 2005
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Migraine only during the menstrual period
- Migraine attacks each menstrual period during the last year
- Regular menstrual cycle
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 17-beta-estradiol (drug) | Drug | – |
Primary outcome
Number of migraine attacks
Severeity of migraine attacks
Analgetics used
1 secondary outcome
Bleeding disturbances
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2005.
- Derived from this study: PubMed 21704313Almen-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Brynhildsen principal investigator
Department of Obstetrics & Gynecology, University Hospital, SE-58185, Linköping, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 17-beta-estradiol (drug) in people with Migraine, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of migraine attacks. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00204074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2005.