Status:
COMPLETED
Boston Migraine and Contraception Study
Lead Sponsor:
Planned Parenthood League of Massachusetts
Collaborating Sponsors:
Brigham and Women's Hospital
American Headache Society
Conditions:
Headache
Eligibility:
FEMALE
18-65 years
Brief 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 contra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT01216358
Start Date
October 1 2010
End Date
December 1 2011
Last Update
May 10 2012
Active Locations (1)
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1
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States, 02215