Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-01-25 @ 6:35 AM
Study NCT ID:
NCT01731132
Status:
COMPLETED
Last Update Posted:
2015-07-16
First Post:
2012-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-15', 'studyFirstSubmitDate': '2012-09-17', 'studyFirstSubmitQcDate': '2012-11-16', 'lastUpdatePostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact on quality of life of women initiating IUD in a Spanish population assessed by questionnaire.', 'timeFrame': 'After 12 months'}], 'secondaryOutcomes': [{'measure': 'Demographic Data (Age, Place of Birth, Level of Education, Employment status, Personal marital situation, etc.) assessed by questionnaire.', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HRQoL', 'IUD', 'Contraception', 'SEC-QoL'], 'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': 'Knowledge about the impact on quality of life of women initiating IUD in the Spanish population at baseline and after 12 months of use.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women who starts contraception with an IUD.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-49 years old female.\n* Women who is visited by a gynecology or primary care physician and starts contraception with an IUD/IUS.\n* Women that has not used hormonal contraception in any form in the last 3 months.\n* Women who have no problems listening, reading or writing.\n* Women who gives their written consent to participate in the study.\n\nExclusion Criteria:\n\n* Women who have contraindications to use IUDs.\n* Women with previous experience with IUDs.\n* Women who initiates the use of IUDs for other purposes other than contraception.\n* Woman who is participating in a clinical trial at the time of initiating the study.'}, 'identificationModule': {'nctId': 'NCT01731132', 'acronym': 'DIUQoL', 'briefTitle': 'DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.', 'orgStudyIdInfo': {'id': '16341'}, 'secondaryIdInfos': [{'id': 'MA1213ES', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': 'BAY-DIU-2011-01', 'type': 'OTHER', 'domain': 'Company Internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Drug: Levonorgestrel IUD or Copper IUD']}], 'interventions': [{'name': 'Levonorgestrel IUD or Copper IUD', 'type': 'DRUG', 'description': 'Women who initiate the use of an IUD at the time of the study.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'Spain'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}