Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-27 @ 9:41 PM
Study NCT ID:
NCT00302666
Status:
COMPLETED
Last Update Posted:
2009-05-18
First Post:
2006-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bleeding Pattern Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1315}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-15', 'studyFirstSubmitDate': '2006-02-23', 'studyFirstSubmitQcDate': '2006-03-13', 'lastUpdatePostDateStruct': {'date': '2009-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bleeding pattern'}], 'secondaryOutcomes': [{'measure': 'Safety, contraceptive efficacy'}]}, 'conditionsModule': {'keywords': ['Contraception, Bleeding pattern'], 'conditions': ['Oral Contraceptive']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate bleeding pattern, cycle control, contraceptive efficacy and safety of this oral contraceptive in two different regimens of intake.', 'detailedDescription': 'The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.\n\nBayer Schering Pharma AG, Germany is the sponsor of the trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy female volunteers aged between 18 and 40 years requiring contraception.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Any conditions that might interfere with the outcome as well as all contraindications for OC use.'}, 'identificationModule': {'nctId': 'NCT00302666', 'briefTitle': 'Bleeding Pattern Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Comparative, Prospective, Multi-Center, Open, Randomized Study to Investigate Bleeding Patterns, Metabolic Effects, Contraceptive Efficacy, Acceptance, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 2 mg Dienogest, in Two Different Regimens of Intake (Four Extended Cycles of 84 Days Each Versus the Conventional Regimen of 21 Days) in Healthy Volunteers', 'orgStudyIdInfo': {'id': '91227'}, 'secondaryIdInfos': [{'id': '306903'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Arm 1', 'interventionNames': ['Drug: Valette (Dienogest/EE30, BAY86-5038)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Arm 2', 'interventionNames': ['Drug: Valette (Dienogest/EE30, BAY86-5038)']}], 'interventions': [{'name': 'Valette (Dienogest/EE30, BAY86-5038)', 'type': 'DRUG', 'description': 'Oral contraceptive extended cycles', 'armGroupLabels': ['Arm 1']}, {'name': 'Valette (Dienogest/EE30, BAY86-5038)', 'type': 'DRUG', 'description': 'Oral contraceptive conventional cycles', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69412', 'city': 'Eberbach', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'geoPoint': {'lat': 49.4668, 'lon': 8.99016}}, {'zip': '91315', 'city': 'Höchstadt A. 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'07318', 'city': 'Saalfeld', 'state': 'Thuringia', 'country': 'Germany', 'geoPoint': {'lat': 50.64826, 'lon': 11.36536}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Therapeutic Area Head', 'oldOrganization': 'Bayer Schering Pharma AG'}}}}