Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT01643304
Status:
COMPLETED
Last Update Posted:
2013-11-21
First Post:
2012-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Swedish Questionnaire Study to Investigate the Perception of Menstrual Bleedings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008595', 'term': 'Menorrhagia'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1547}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-20', 'studyFirstSubmitDate': '2012-07-16', 'studyFirstSubmitQcDate': '2012-07-17', 'lastUpdatePostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of subjectively experienced heavy menstrual bleeding assessed by questionnaire', 'timeFrame': 'Once at baseline'}], 'secondaryOutcomes': [{'measure': 'Social consequences of heavy menstrual bleedings assessed by questionnaire', 'timeFrame': 'Once at baseline'}, {'measure': 'Costs; e.g. pads, absence from work, loss of income assessed by questionnaire', 'timeFrame': 'Once at baseline'}, {'measure': 'The treatments given for heavy menstrual bleedings, as surgery or medication assessed by questionnaire', 'timeFrame': 'Once at baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Menorrhagia', 'Heavy menstrual bleeding', 'Uterine Hemorrhage', 'Menstruation Disturbancies'], 'conditions': ['Menorrhagia']}, 'descriptionModule': {'briefSummary': 'This field based, questionnaire study will document observational data on womens perception of menstrual bleeding in a cross-section of women in Sweden. Each subject will complete the questionnaire at one occasion.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects included in the SIFO (Swedish institute of market research) volontary subject pool.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women 40-45 years available in the web-panel of SIFO\n* Completion of the web-based questionnaire\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01643304', 'briefTitle': 'A Swedish Questionnaire Study to Investigate the Perception of Menstrual Bleedings', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Swedish Cross-sectional Study With Questionnaire to Investigate Perception of Menstrual Bleeding', 'orgStudyIdInfo': {'id': '16384'}, 'secondaryIdInfos': [{'id': 'NN1223SE', 'type': 'OTHER', 'domain': 'Company Internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Behavioral: No drug']}], 'interventions': [{'name': 'No drug', 'type': 'BEHAVIORAL', 'description': 'No drug intervention. The intervention is a questionnaire with quality of life and perception of menstrual bleedings. All subjects will complete both questionnaires.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'Sweden'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}