Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-30 @ 8:01 AM
Study NCT ID:
NCT00998257
Status:
COMPLETED
Last Update Posted:
2015-01-21
First Post:
2009-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regulatory Post Marketing Surveillance Study on YAZ
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011293', 'term': 'Premenstrual Syndrome'}, {'id': 'D000152', 'term': 'Acne Vulgaris'}, {'id': 'D065446', 'term': 'Premenstrual Dysphoric Disorder'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C534342', 'term': 'drospirenone and ethinyl estradiol combination'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 770}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-19', 'studyFirstSubmitDate': '2009-09-21', 'studyFirstSubmitQcDate': '2009-10-19', 'lastUpdatePostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse event collection', 'timeFrame': 'After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)'}, {'measure': 'Contraception efficacy', 'timeFrame': 'After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)'}, {'measure': 'Drug compliance', 'timeFrame': 'After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)'}, {'measure': 'Release of Premenstrual Dysphoric Disorder (PMDD) or acne', 'timeFrame': 'After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)'}], 'secondaryOutcomes': [{'measure': 'Number of patients who used YAZ just for contraception', 'timeFrame': 'At initial visit (Day 0)'}, {'measure': 'Number of patients who used YAZ for PMDD + contraception', 'timeFrame': 'At initial visit (Day 0)'}, {'measure': 'Number of patients who used YAZ for Acne + contraception', 'timeFrame': 'At initial visit (Day 0)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contraception', 'Premenstrual Dysphoric Disorder', 'PMDD', 'Acne'], 'conditions': ['Contraception', 'Premenstrual Syndrome', 'Acne']}, 'descriptionModule': {'briefSummary': 'The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Korean female who need only contraception or contraception and management of PMDD or contraception and treatment of acne.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy female subjects\n\n * requesting contraception\n * suggesting PMDD by Physician who are also requesting contraception\n * with acne who are also requesting contraception\n* Age: 18 - 50 years\n* Women who is prescribed YAZ first, during study period\n\nExclusion Criteria:\n\n* Women who are contraindicated based on the label of YAZ\n\n * Presence or a history of venous or arterial thrombotic/ thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident\n * Presence or history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris)\n * History of migraine with focal neurological symptoms\n * Diabetes mellitus with vascular involvement\n * The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication\n * Pancreatitis or a history thereof if associated with severe hypertriglyceridemia\n * Presence or history of severe hepatic disease as long as liver function values have not returned to normal\n * Severe renal insufficiency or acute renal failure\n * Presence or history of liver tumours (benign or malignant)\n * Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts)\n * Undiagnosed vaginal bleeding\n * Known or suspected pregnancy\n * Hypersensitivity to the active substances or to any of the excipients'}, 'identificationModule': {'nctId': 'NCT00998257', 'briefTitle': 'Regulatory Post Marketing Surveillance Study on YAZ', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Regulatory Post Marketing Surveillance Study on YAZ', 'orgStudyIdInfo': {'id': '14785'}, 'secondaryIdInfos': [{'id': 'YA0910KR', 'type': 'OTHER', 'domain': 'company internal'}, {'id': 'YAZ rPMS', 'type': 'OTHER', 'domain': 'company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Drug: EE20/DRSP (YAZ, BAY86-5300)']}], 'interventions': [{'name': 'EE20/DRSP (YAZ, BAY86-5300)', 'type': 'DRUG', 'description': 'Patients under daily life treatment with YAZ according to local drug information.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'South Korea'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}