NCT00204074

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2001

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

December 29, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

December 28, 2005

Conditions

Migraine

Keywords

MigraineMenstrual cycle17 beta-estradiolTransdermal administration

Outcome Measures

Primary Outcomes (3)

  • Number of migraine attacks

  • Severeity of migraine attacks

  • Analgetics used

Secondary Outcomes (1)

  • Bleeding disturbances

Interventions

17-beta-estradiol (drug)DRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)

You may qualify if:

  • Migraine only during the menstrual period
  • Migraine attacks each menstrual period during the last year
  • Regular menstrual cycle

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Obstetrics & Gynecology, Department of Molecular and Clinical Medicine, Faculty of Health Sciences

Linköping, SE-58185, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 21704313DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

EstradiolPharmaceutical Preparations

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Jan Brynhildsen

    Department of Obstetrics & Gynecology, University Hospital, SE-58185, Linköping, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

October 1, 2001

Study Completion

July 1, 2005

Last Updated

December 29, 2005

Record last verified: 2005-09

Locations

SE(1)