Prospective Survey of Menstrual Migraine & Prevention With Eletriptan

This study has been completed.

First Received: November 26, 2005 Last Updated: November 11, 2008 History of Changes

Sponsors and Collaborators:	University of Pittsburgh Pfizer
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00259649

Purpose

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.

Condition	Intervention	Phase
Migraine	Drug: eletriptan	Phase IV

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Assessment and Prevention of Menstrual Migraine: Phase 1-Prospective Survey of Self-Identified Menstrual Migraine. Phase 2-Prevention of Menstrual Migraine With Relpax

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Menstruation Migraine

Drug Information available for: Eletriptan Eletriptan Hydrobromide

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Change in headache index

Estimated Enrollment:	175
Study Start Date:	August 2004
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

age 18-45 healthy menstruating female

Exclusion Criteria:

cardiac or other conditions precluding use of eletriptan

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259649

Locations

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15206

Sponsors and Collaborators

University of Pittsburgh

Pfizer

Investigators

Principal Investigator:

Dawn Marcus, MD

University of Pittsburgh

More Information

No publications provided

Study ID Numbers:	901423
Study First Received:	November 26, 2005
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00259649 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Serotonin Agonists
Eletriptan
Neurotransmitter Agents
Menstruation Disturbances
Migraine Disorders
Headache

Central Nervous System Diseases
Headache Disorders, Primary
Brain Diseases
Serotonin
Premenstrual Syndrome
Headache Disorders

Additional relevant MeSH terms:

Eletriptan
Serotonin Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Headache Disorders, Primary

Brain Diseases
Pharmacologic Actions
Headache Disorders
Pathologic Processes
Serotonin Agents
Menstruation Disturbances
Migraine Disorders
Premenstrual Syndrome

ClinicalTrials.gov processed this record on July 02, 2009