Boston Migraine and Contraception Study (BMAC)

Planned Parenthood League of Massachusetts

Status: Completed

Conditions: Headache

Study type: Observational

Funder types: Other

Identifiers

NCT01216358

2009P000464

Details and patient eligibility

About

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.

Enrollment: 171 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

171 participants in 3 patient groups

Arm 1: Combined contraceptive

Description:

Initiating an estrogen/progesterone contraceptive

Arm 2: Progesterone only contraceptive

Description:

Initiating a progesterone-only contraceptive

Arm 3 (control): Non-hormonal contraceptive

Description:

Initiating or using non-hormonal contraception or not using contraception