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Trial record 1 of 1 for:    NCT00259649
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Prospective Survey of Menstrual Migraine & Prevention With Eletriptan

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ClinicalTrials.gov Identifier: NCT00259649
Recruitment Status : Completed
First Posted : November 29, 2005
Results First Posted : July 4, 2011
Last Update Posted : July 4, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE November 26, 2005
First Posted Date  ICMJE November 29, 2005
Results First Submitted Date  ICMJE May 26, 2011
Results First Posted Date  ICMJE July 4, 2011
Last Update Posted Date July 4, 2011
Study Start Date  ICMJE August 2004
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2011)
Change in Mean Headache Index Score Among Patients [ Time Frame: baseline to approximately three months ]
Headache index is an average headache severity score recorded using a 0-10 severity scale recorded 4 times daily. Scores are averaged to produce an average severity score which can range between 0 (no headaches) to 10 (always a maximum severity headache). Change in headache activity was evaluated by comparing mean severity scores during the 3 months pre-intervention are compared with 3 months of preventive therapy
Original Primary Outcome Measures  ICMJE
 (submitted: November 26, 2005)
Change in headache index
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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, MD University 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