Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-24 @ 1:00 PM
Study NCT ID:
NCT02159261
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2014-06-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assess Satisfaction of Patients and Physicians With Results of Yaz Plus Treatment for 13 Cycles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-08', 'studyFirstSubmitDate': '2014-06-06', 'studyFirstSubmitQcDate': '2014-06-06', 'lastUpdatePostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satisfaction measured with a Likert response scale (from 1 - poor to 5 - excellent)', 'timeFrame': 'Up to 12 months'}], 'secondaryOutcomes': [{'measure': 'Changes in EVAPIL scale for assessment of tolerability of oral contraceptives.', 'timeFrame': 'Baseline to 12 months'}, {'measure': 'Number of participants with adverse events as a measure of safety and tolerability', 'timeFrame': 'Up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Personal Satisfaction'], 'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': "Local prospective multicenter non-comparative non-interventional observational study. It's planed to assess satisfaction of patients and physicians with results of Yaz Plus treatment for 13 cycles in real practice.", 'detailedDescription': 'Non-interventional, Yaz Plus, Contraception, Assess satisfaction, Russian Federation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients ≥ 18 years old requiring contraception, treated with Yaz Plus for the first time and for which the inclusion and exclusion criteria are fulfilled, are eligible for enrolment into the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients ≥ 18 years old\n* Requiring contraception\n* Prescribed with Yaz Plus for the first time\n\nExclusion Criteria:\n\n* Contraindications for the use of Yaz Plus in accordance with the local product information'}, 'identificationModule': {'nctId': 'NCT02159261', 'briefTitle': 'Assess Satisfaction of Patients and Physicians With Results of Yaz Plus Treatment for 13 Cycles', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Prospective Multicenter Non-interventional Study on Patients and Physicians Satisfaction of Yaz Plus', 'orgStudyIdInfo': {'id': '17177'}, 'secondaryIdInfos': [{'id': 'YZ1410RU', 'type': 'OTHER', 'domain': 'Company Internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Female patients ≥ 18 years old requiring contraception.', 'interventionNames': ['Drug: BAY98-7071_EE20/DRSP/L-5-MTHF']}], 'interventions': [{'name': 'BAY98-7071_EE20/DRSP/L-5-MTHF', 'type': 'DRUG', 'description': 'Patients treated by Physicians under approved local prescriptions', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'Russia'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}