MedTrace Logo

Boston Migraine and Contraception Study

NCT01216358 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 171

Last updated 2012-05-10

No results posted yet for this study

Summary

The objectives of this prospective, descriptive study are to:

1. generate estimates of the incidence, prevalence, persistence, clinical impact and attributable risk of migraine due to hormonal contraception (HC) use; and
2. identify predictive factors for clinically significant changes in headache attributable to HC use.

The investigators hypothesize that:

1. Most women with pre-existing migraine will have no significant change from baseline headache frequency or clinical impact attributable to HC at 3 months following initiation; a minority will report clinically significant worsening or improvement
2. The incidence of headache and migraine in HC users will not be significantly different from their incidence in NHC users
3. There will be identifiable risk factors for development or worsening of headache/migraine in the minority of HC users where that occurs.

Conditions

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • American Headache Society

    collaborator OTHER

  • Society of Family Planning

    collaborator OTHER

  • Planned Parenthood League of Massachusetts

    lead OTHER

Principal Investigators

  • Principal Investigator, MD · Planned Parenthood League of Massachusetts

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01216358 on ClinicalTrials.gov