Clinical trial NCT01216358: Boston Migraine and Contraception Study
Official title: The Boston Migraine and Contraception Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache
Keywords: Headache
Contraception
Lead sponsor: Planned Parenthood League of Massachusetts
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: American Headache Society
name: Society of Family Planning
First posted: 2010-10-07
Enrollment: 171
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health female adults, patients of Planned Parenthood League of Massachusetts

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of days with headache
timeFrame: 84 days
Secondary outcomes:
measure: Averages for percentage of headache days/28 days
timeFrame: 84 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Planned Parenthood League of Massachusetts
state: Massachusetts
Study officials:
affiliation: Planned Parenthood League of Massachusetts
name: Principal Investigator, MD
role: PRINCIPAL_INVESTIGATOR
References: