Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00397202
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2006-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FLOW-Finding Lasting Options for Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-29', 'studyFirstSubmitDate': '2006-11-06', 'studyFirstSubmitQcDate': '2006-11-07', 'lastUpdatePostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall satisfaction with menstrual strategy.'}], 'secondaryOutcomes': [{'measure': 'Diagnosed UTI'}, {'measure': 'Diagnosed vaginitis'}, {'measure': 'Vaginal irritation'}, {'measure': 'Waste'}, {'measure': 'Cost'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Menstruation'], 'conditions': ['Menstruation']}, 'referencesModule': {'references': [{'pmid': '21673197', 'type': 'DERIVED', 'citation': 'Howard C, Rose CL, Trouton K, Stamm H, Marentette D, Kirkpatrick N, Karalic S, Fernandez R, Paget J. FLOW (finding lasting options for women): multicentre randomized controlled trial comparing tampons with menstrual cups. Can Fam Physician. 2011 Jun;57(6):e208-15.'}]}, 'descriptionModule': {'briefSummary': '1. Purpose: To compare the use of the menstrual cup "The DivaCupTM " to a menstrual strategy using tampons as the primary method of menstrual flow management using indicators of user-satisfaction, urinary tract infection, vaginal irritation, cost and waste.\n2. Hypothesis: The "The DivaCupTM" will have similar rates of user-satisfaction, urinary tract infection, and vaginal irritation as a menstrual strategy using tampons as the primary method of menstrual flow management but will likely be more reasonable in terms of cost and will generate less waste.', 'detailedDescription': 'Method:\n\nProspective study of 100 women from family practice offices in Vancouver, Victoria and Prince George who currently use tampons to manage menstrual flow. After an information session and consent, subjects will be randomized to tampon use or Diva Cup use and record their experience on a diary for 3 months. Women who attend the information session and who do not enrol, or those who drop out will be asked their reasons for discontinuing, and their pre-study questionnaire will be used for analysis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women between the ages of 19 and 40 who have menstrual flow most months and who currently self-identify as using tampons as their primary method of menstrual management\n\nExclusion Criteria:\n\n* Have a sensitivity or allergy to silicone\n* Have an active vaginal or urogenital infection\n* Are pregnant, or who have plans to become pregnant before spring 2007 (end of study data collection)\n* Have used systemic antimicrobials within the previous 14 days\n* Are unable to understand the nature and purpose of the study\n* Are unable to understand and express themselves in written and spoken English'}, 'identificationModule': {'nctId': 'NCT00397202', 'briefTitle': 'FLOW-Finding Lasting Options for Women', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'FLOW-Finding Lasting Options for Women: A Prospective, Randomized, Multicenter Trial Comparing Tampons to a Menstrual Cup', 'orgStudyIdInfo': {'id': 'H06-70478'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'The DivaCupTM', 'interventionNames': ['Device: Diva Cup TM']}], 'interventions': [{'name': 'Diva Cup TM', 'type': 'DEVICE', 'description': 'See Detailed Description.', 'armGroupLabels': ['The DivaCupTM']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Victoria, Vancouver, Prince George', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Private family physician offices'}], 'overallOfficials': [{'name': 'Konia Trouton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research System-College of Family Physicians of Canada', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}