Boston Migraine and Contraception Study

NCT01216358 | Completed

• 1 other identifier: 2009P000464
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this prospective, descriptive study are to:

1. 1.generate estimates of the incidence, prevalence, persistence, clinical impact and attributable risk of migraine due to hormonal contraception (HC) use; and
2. 2.identify predictive factors for clinically significant changes in headache attributable to HC use.
3. 3.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
4. 4.The incidence of headache and migraine in HC users will not be significantly different from their incidence in NHC users
5. 5.There will be identifiable risk factors for development or worsening of headache/migraine in the minority of HC users where that occurs.

Conditions

Headache

Keywords

Headache; Contraception

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Averages for percentage of headache days/28 days

  84 days

Study Arms (3)

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 Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Health female adults, patients of Planned Parenthood League of Massachusetts

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

Sponsors & Collaborators

• Planned Parenthood League of Massachusetts: lead
• Brigham and Women's Hospital: collaborator
• American Headache Society: collaborator
• Society of Family Planning: collaborator

Study Sites (1)

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Principal Investigator, MD

  Planned Parenthood League of Massachusetts

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 7, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 10, 2012

Record last verified: 2012-05

Locations

US (1)