Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-19 @ 1:15 AM
Study NCT ID:
NCT00280657
Status:
COMPLETED
Last Update Posted:
2023-06-06
First Post:
2006-01-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Safety and Efficacy of an Oral Contraceptive in Treating Acne Papulopustulosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003534', 'term': 'Cyproterone'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013258', 'term': 'Steroids, Chlorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1326}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2005-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-05', 'studyFirstSubmitDate': '2006-01-20', 'studyFirstSubmitQcDate': '2006-01-20', 'lastUpdatePostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in lesions', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'ISGA', 'timeFrame': '6 months'}, {'measure': 'Parameters of safety and tolerability', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acne papulopustulosa'], 'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine safety and efficacy of an oral contraceptive in treating acne papulopustulosa.', 'detailedDescription': 'The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with mild to moderate facial papulopustular acne\n\nExclusion Criteria:\n\n* Contraindication against use of hormonal contraceptives'}, 'identificationModule': {'nctId': 'NCT00280657', 'briefTitle': 'Study on Safety and Efficacy of an Oral Contraceptive in Treating Acne Papulopustulosa', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Multicenter, Double-blind, Double-dummy, Randomized Parallel Group Study to Evaluate the Safety and Efficacy of SH D 00659 E for 6 Treatment Cycles in Female Patients With Acne Papulopustulosa in Comparison to SH D 00659 G and Placebo.', 'orgStudyIdInfo': {'id': '91299'}, 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