Prospective Survey of Menstrual Migraine & Prevention With Eletriptan

This study has been completed.

Study NCT00259649 Information provided by University of Pittsburgh

First Received on November 26, 2005. Last Updated on July 1, 2011 History of Changes

Results First Received: May 26, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Migraine
Intervention:	Drug: eletriptan

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Eletriptan	Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months

Participant Flow: Overall Study

	Eletriptan
STARTED	71
COMPLETED	61
NOT COMPLETED	10
Lost to Follow-up	7
irregular menses	3

Baseline Characteristics

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Reporting Groups

	Description
Eletriptan	Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months

Baseline Measures

	Eletriptan
Number of Participants [units: participants]	71
Age [units: participants]
<=18 years	0
Between 18 and 65 years	71
>=65 years	0
Gender [units: participants]
Female	71
Male	0
Region of Enrollment [units: participants]
United States	71

Outcome Measures

1. Primary:

Change in Mean Headache Index Score Among Patients [ Time Frame: baseline to approximately three months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Relatively small sample size and open-label treatment limit Menstrual regulation by hormonal therapy might have affected treatment response;

Results Point of Contact:

Name/Title: Dawn marcus
Organization: University of Pittsburgh
phone: 412-953-4797
e-mail: marcusd@upmc.edu

No publications provided

Responsible Party:	Dawn marcus, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00259649 History of Changes
Other Study ID Numbers:	901423
Study First Received:	November 26, 2005
Results First Received:	May 26, 2011
Last Updated:	July 1, 2011
Health Authority:	United States: Food and Drug Administration