Boston Migraine and Contraception Study

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.

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Key information

Conditions

Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Proportion of days with headache

Time frame: 84 days

Our primary outcome is the change in the proportion of headache days over 84 days, adjusted for baseline headache frequency

Secondary outcomes

Averages for percentage of headache days/28 days

Time frame: 84 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

Sponsors and collaborators

Lead sponsor

Planned Parenthood League of Massachusetts

Other

Collaborators

American Headache Society
Brigham and Women's Hospital
Society of Family Planning

Registry information

Official study title

The Boston Migraine and Contraception Study

Acronym: BMAC

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Oct 7, 2010
Registry last updated: May 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed