Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT01216358
Status:
COMPLETED
Last Update Posted:
2012-05-10
First Post:
2010-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Boston Migraine and Contraception Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-08', 'studyFirstSubmitDate': '2010-10-06', 'studyFirstSubmitQcDate': '2010-10-06', 'lastUpdatePostDateStruct': {'date': '2012-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of days with headache', 'timeFrame': '84 days', 'description': 'Our primary outcome is the change in the proportion of headache days over 84 days, adjusted for baseline headache frequency'}], 'secondaryOutcomes': [{'measure': 'Averages for percentage of headache days/28 days', 'timeFrame': '84 days', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Headache', 'Contraception'], 'conditions': ['Headache']}, 'descriptionModule': {'briefSummary': 'The objectives of this prospective, descriptive study are to:\n\n1. generate estimates of the incidence, prevalence, persistence, clinical impact and attributable risk of migraine due to hormonal contraception (HC) use; and\n2. identify predictive factors for clinically significant changes in headache attributable to HC use.\n\nThe investigators hypothesize that:\n\n1. 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\n2. The incidence of headache and migraine in HC users will not be significantly different from their incidence in NHC users\n3. There will be identifiable risk factors for development or worsening of headache/migraine in the minority of HC users where that occurs.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Health female adults, patients of Planned Parenthood League of Massachusetts', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Proficiency in English\n* Medically eligible for her chosen form of contraception per standard PPLM clinic protocol\n* (For Study Arm A) Desire initiation of an estrogen/progesterone contraceptive method at time of clinic presentation and evaluation\n* (For Study Arm B) Desire initiation of a progesterone only contraceptive method at time of clinic presentation and evaluation\n* (For Control Arm) Initiating a non-hormonal contraceptive, or not initiating any contraceptive method\n* (For Control Arm) Stated intention of not initiating any hormonal contraception over the 3 month study period\n* Agreeing to study procedures\n\nExclusion Criteria:\n\n* Inability to speak and read English\n* (For Control Arm) Use of hormonal contraceptive in the past 3 months\n* (For Control Arm) Been pregnant in the past 3 months\n* States an intention to discontinue use of their newly initiated contraceptive (or lack of contraceptive) before the end of the 3 month study period\n* Unwilling or unable to comply with study follow-up procedures\n* Inability to give informed consent\n* Previous participation in this study'}, 'identificationModule': {'nctId': 'NCT01216358', 'acronym': 'BMAC', 'briefTitle': 'Boston Migraine and Contraception Study', 'organization': {'class': 'OTHER', 'fullName': 'Planned Parenthood League of Massachusetts'}, 'officialTitle': 'The Boston Migraine and Contraception Study', 'orgStudyIdInfo': {'id': '2009P000464'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm 1: Combined contraceptive', 'description': 'Initiating an estrogen/progesterone contraceptive'}, {'label': 'Arm 2: Progesterone only contraceptive', 'description': 'Initiating a progesterone-only contraceptive'}, {'label': 'Arm 3 (control): Non-hormonal contraceptive', 'description': 'Initiating or using non-hormonal contraception or not using contraception'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Planned Parenthood League of Massachusetts', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Principal Investigator, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Planned Parenthood League of Massachusetts'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Planned Parenthood League of Massachusetts', 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'American Headache Society', 'class': 'OTHER'}, {'name': 'Society of Family Planning', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}