Boston Migraine and Contraception Study

Headache Clinical Trial

— BMAC  

Official title:

The Boston Migraine and Contraception Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216358
• Other study ID #: 2009P000464
• Status: Completed
• Phase: N/A
• First received: October 6, 2010
• Last updated: May 8, 2012
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: May 2012
• Source: Planned Parenthood League of Massachusetts
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Headache

Locations

Country	Name	City	State
United States	Planned Parenthood League of Massachusetts	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Planned Parenthood League of Massachusetts	American Headache Society, Brigham and Women's Hospital, Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No