HeadacheBMACNCT01216358
Boston Migraine and Contraception Study
An observational study of Headache, run by Planned Parenthood League of Massachusetts at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Headache
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health female adults, patients of Planned Parenthood League of Massachusetts
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood League of Massachusetts
Boston, Massachusetts, 02215
About this study
Official title: The Boston Migraine and Contraception Study
The objectives of this prospective, descriptive study are to:
- generate estimates of the incidence, prevalence, persistence, clinical impact and attributable risk of migraine due to hormonal contraception (HC) use; and
- identify predictive factors for clinically significant changes in headache attributable to HC use.
Read more
The investigators hypothesize that:
- 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
- The incidence of headache and migraine in HC users will not be significantly different from their incidence in NHC users
- 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
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 84 days
Secondary outcomes (1)
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
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Planned Parenthood League of Massachusetts
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, American Headache Society, Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Principal Investigator, MD, Principal investigator, Planned Parenthood League of Massachusetts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216358
- Sponsor's protocol ID
- 2009P000464
- Acronym
- BMAC
- Status last verified
- May 2012
- First submitted
- 6 Oct 2010
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Boston Migraine and Contraception Study
- ClinicalTrials.gov ID
- NCT01216358
- Acronym / sponsor ID
- BMAC / 2009P000464
- Conditions
- Headache
- Keywords
- Headache, Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Planned Parenthood League of MassachusettsUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, American Headache Society, Society of Family Planning
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this prospective, descriptive study are to:
- generate estimates of the incidence, prevalence, persistence, clinical impact and attributable risk of migraine due to hormonal contraception (HC) use; and
- identify predictive factors for clinically significant changes in headache attributable to HC use.
The investigators hypothesize that:
- 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
- The incidence of headache and migraine in HC users will not be significantly different from their incidence in NHC users
- There will be identifiable risk factors for development or worsening of headache/migraine in the minority of HC users where that occurs.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health female adults, patients of Planned Parenthood League of Massachusetts
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of days with headache
Time frame: 84 days
Our primary outcome is the change in the proportion of headache days over 84 days, adjusted for baseline headache frequency
1 secondary outcome
Averages for percentage of headache days/28 days
Time frame: 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Principal Investigator, MD principal investigator
Planned Parenthood League of Massachusetts
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache, run by Planned Parenthood League of Massachusetts at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of days with headache (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2012.