Boston Migraine and Contraception Study

Study Overview
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Brief Summary
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The objectives of this prospective, descriptive study are to: generate estimates of the incidence, prevalence, persistence, clinical impact and attributable risk of migraine due to hormonal contraception (HC) use; and identify predictive factors for clinically significant changes in headache attributable to HC use. The investigators hypothesize that: 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 The incidence of headache and migraine in HC users will not be significantly different from their incidence in NHC users There will be identifiable risk factors for development or worsening of headache/migraine in the minority of HC users where that occurs.

Official Title
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The Boston Migraine and Contraception Study

Conditions
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Headache

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Proficiency in English Medically eligible for her chosen form of contraception per standard PPLM clinic protocol (For Study Arm A) Desire initiation of an estrogen/progesterone contraceptive method at time of clinic presentation and evaluation (For Study Arm B) Desire initiation of a progesterone only contraceptive method at time of clinic presentation and evaluation (For Control Arm) Initiating a non-hormonal contraceptive, or not initiating any contraceptive method (For Control Arm) Stated intention of not initiating any hormonal contraception over the 3 month study period Agreeing to study procedures Exclusion Criteria: Inability to speak and read English (For Control Arm) Use of hormonal contraceptive in the past 3 months (For Control Arm) Been pregnant in the past 3 months States an intention to discontinue use of their newly initiated contraceptive (or lack of contraceptive) before the end of the 3 month study period Unwilling or unable to comply with study follow-up procedures Inability to give informed consent Previous participation in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm 1: Combined contraceptive<br>Initiating an estrogen/progesterone contraceptive | |
| Arm 2: Progesterone only contraceptive<br>Initiating a progesterone-only contraceptive | |
| Arm 3 (control): Non-hormonal contraceptive<br>Initiating or using non-hormonal contraception or not using contraception | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of days with headache | Our primary outcome is the change in the proportion of headache days over 84 days, adjusted for baseline headache frequency | 84 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Averages for percentage of headache days/28 days | Our secondary outcome will compare averages for the percentage of headache days/28 days for the days 1-28, days 29-56 and days 57-84, adjusted for baseline frequency | 84 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Headache, Contraception