Boston Migraine and Contraception Study

Completed

Conditions studied: Headache

In brief

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.

Key facts

Study ID

NCT01216358

Run by

Planned Parenthood League of Massachusetts

People needed

171

Starts

2010-10-01

Expected to finish

2011-12-01

Last updated by the study team

2012-05-10

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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