Boston Migraine and Contraception Study (BMAC)

The 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.

Study Overview

• Status: Completed
• Conditions: Headache

• Study Type: Observational
• Enrollment (Actual): 171

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Planned Parenthood League of Massachusetts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Health female adults, patients of Planned Parenthood League of Massachusetts

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Arm 1: Combined contraceptive; Initiating an estrogen/progesterone contraceptive
Arm 2: Progesterone only contraceptive; Initiating a progesterone-only contraceptive
Arm 3 (control): Non-hormonal contraceptive; Initiating or using non-hormonal contraception or not using contraception

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Planned Parenthood League of Massachusetts
• Collaborators: Brigham and Women's Hospital; Society of Family Planning; American Headache Society
• Investigators: Principal Investigator: Principal Investigator, MD, Planned Parenthood League of Massachusetts

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: October 6, 2010
• First Submitted That Met QC Criteria: October 6, 2010
• First Posted (Estimate): October 7, 2010

Study Record Updates

• Last Update Posted (Estimate): May 10, 2012
• Last Update Submitted That Met QC Criteria: May 8, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Headache; Contraception
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache
• Other Study ID Numbers: 2009P000464