Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
171 participants
OBSERVATIONAL
2010-10-31
2011-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Arm 1: Combined contraceptive
Initiating an estrogen/progesterone contraceptive
No interventions assigned to this group
Arm 2: Progesterone only contraceptive
Initiating a progesterone-only contraceptive
No interventions assigned to this group
Arm 3 (control): Non-hormonal contraceptive
Initiating or using non-hormonal contraception or not using contraception
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* (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
18 Years
65 Years
FEMALE
Yes
Sponsors
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Brigham and Women's Hospital
OTHER
American Headache Society
OTHER
Society of Family Planning
OTHER
Planned Parenthood League of Massachusetts
OTHER
Responsible Party
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Principal Investigators
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Principal Investigator, MD
Role: PRINCIPAL_INVESTIGATOR
Planned Parenthood League of Massachusetts
Locations
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Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2009P000464
Identifier Type: -
Identifier Source: org_study_id
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