Prospective Survey of Menstrual Migraine & Prevention With Eletriptan - Tabular View

Tracking Information

First Received Date ^ICMJE

November 26, 2005

Last Updated Date

November 11, 2008

Start Date ^ICMJE

August 2004

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in headache index

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00259649 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Migraine

Intervention ^ICMJE

Drug: eletriptan

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

175

Completion Date

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

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00259649

Responsible Party

Study ID Numbers ^ICMJE

901423

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

Pfizer

Investigators ^ICMJE

Principal Investigator:

Dawn Marcus, MD

University of Pittsburgh

Information Provided By

University of Pittsburgh

Verification Date

November 2008

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