Skip to content

Treatment of Menstrual Migraine With Sequential, Transdermal, 17-Beta-Estradiol. A Double-Blind, Randomised, Cross-Over Trial.

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00204074
Enrollment
Unknown
Registered
2005-09-20
Start date
2001-10-31
Completion date
2005-07-31
Last updated
2005-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

Migraine, Menstrual cycle, 17 beta-estradiol, Transdermal administration

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.

Interventions

DRUG17-beta-estradiol (drug)

Sponsors

University Hospital, Linkoeping
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years

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

Design outcomes

Primary

MeasureTime frame
Number of migraine attacks
Severeity of migraine attacks
Analgetics used

Secondary

MeasureTime frame
Bleeding disturbances

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026