Prospective Survey of Menstrual Migraine & Prevention With Eletriptan
NCT00259649
Last updated date
ABOUT THIS STUDY
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 Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Migraine
Sex
Female
Age
18-45 years
Inclusion Criteria
Show details
- age 18-45 healthy menstruating female
Exclusion Criteria
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 | 71 | |||
Original Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |