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Boston Migraine and Contraception Study (BMAC)

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
American Headache Society
Society of Family Planning
Information provided by (Responsible Party):
Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier:
NCT01216358
First received: October 6, 2010
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  Purpose

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.

Condition
Headache

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Boston Migraine and Contraception Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Planned Parenthood League of Massachusetts:

Primary Outcome Measures:
  • Proportion of days with headache [ Time Frame: 84 days ] [ Designated as safety issue: No ]
    Our primary outcome is the change in the proportion of headache days over 84 days, adjusted for baseline headache frequency


Secondary Outcome Measures:
  • Averages for percentage of headache days/28 days [ Time Frame: 84 days ] [ Designated as safety issue: No ]
    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


Enrollment: 171
Study Start Date: October 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Health female adults, patients of Planned Parenthood League of Massachusetts

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216358

Locations
United States, Massachusetts
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Planned Parenthood League of Massachusetts
Brigham and Women's Hospital
American Headache Society
Society of Family Planning
Investigators
Principal Investigator: Principal Investigator, MD Planned Parenthood League of Massachusetts
  More Information

No publications provided

Responsible Party: Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier: NCT01216358     History of Changes
Other Study ID Numbers: 2009P000464
Study First Received: October 6, 2010
Last Updated: May 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Planned Parenthood League of Massachusetts:
Headache
Contraception

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
 Contraceptive Agents
Progesterone
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 16, 2013