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OpenTrials
Completed

NCT Number: NCT00259649

Prospective Survey of Menstrual Migraine & Prevention With Eletriptan

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15206, United States

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18-45 healthy menstruating female

Exclusion criteria

  • cardiac or other conditions precluding use of eletriptan

Treatment and study plan

eletriptan

Drug

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 names: Relpax

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Pfizer

Registry information

Official study title

Assessment and Prevention of Menstrual Migraine: Phase 1-prospective Survey of Self-identified Menstrual Migraine. Phase 2-prevention of Menstrual Migraine With Relpax

Important dates

Study start
2004
Primary completion
2008
First posted
Nov 29, 2005
Registry last updated
Jul 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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