Prospective Survey of Menstrual Migraine & Prevention With Eletriptan

NCT00259649

Last updated date
Study Location
University of Pittsburgh
Pittsburgh, Pennsylvania, 15206, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Migraine
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- age 18-45 healthy menstruating female

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- cardiac or other conditions precluding use of eletriptan

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Advanced Information
Descriptive Information
Brief Title  ICMJE Prospective Survey of Menstrual Migraine & Prevention With Eletriptan
Official Title  ICMJE Assessment and Prevention of Menstrual Migraine: Phase 1-prospective Survey of Self-identified Menstrual Migraine. Phase 2-prevention of Menstrual Migraine With Relpax
Brief Summary Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months.
Detailed Description Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Migraine
Intervention  ICMJE Drug: eletriptan
oral eletriptan 20 mg three times a day beginning 2 days before the expected onset of menstrual flow and continued for a total of 6 days
Other Name: Relpax
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2011)
71
Original Enrollment  ICMJE
 (submitted: November 26, 2005)
175
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age 18-45 healthy menstruating female

Exclusion Criteria:

  • cardiac or other conditions precluding use of eletriptan
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00259649
Other Study ID Numbers  ICMJE 901423
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dawn marcus, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Dawn Marcus, MDUniversity of Pittsburgh
PRS Account University of Pittsburgh
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP