Viewing Study NCT03253094

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Ignite Creation Date: 2025-12-25 @ 1:46 AM
Ignite Modification Date: 2026-02-25 @ 5:45 PM
Study NCT ID: NCT03253094
Status: COMPLETED
Last Update Posted: 2021-08-12
First Post: 2017-07-14
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002181', 'term': 'Candidiasis, Vulvovaginal'}], 'ancestors': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014848', 'term': 'Vulvovaginitis'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014847', 'term': 'Vulvitis'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015725', 'term': 'Fluconazole'}, {'id': 'C569338', 'term': 'ibrexafungerp'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.angulo@scynexis.com', 'phone': '(201) 884 - 5471', 'title': 'Dr. David Angulo', 'organization': 'SCYNEXIS'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '29 days', 'eventGroups': [{'id': 'EG000', 'title': 'Ibrexafungerp 750-mg', 'description': '750 mg QD D1 only', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 21, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ibrexafungerp 300-mg', 'description': '300 mg BID D1 only', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 13, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ibrexafungerp 450-mg', 'description': '450 mg BID D1 only', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 15, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Ibrexafungerp 150-mg', 'description': '150 mg BID D1 to D3', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 15, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Ibrexafungerp 300-mg D1 to D3', 'description': '300 mg BID D1 to D3', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 18, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Fluconazole', 'description': '150 mg QD D1 only', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 10, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Cure (Complete Resolution of Signs and Symptoms)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp 750-mg', 'description': '750 mg QD D1 only'}, {'id': 'OG001', 'title': 'Ibrexafungerp 300-mg', 'description': '300 mg BID D1 only'}, {'id': 'OG002', 'title': 'Ibrexafungerp 450-mg', 'description': '450 mg BID D1 only'}, {'id': 'OG003', 'title': 'Ibrexafungerp 150-mg', 'description': '150 mg BID D1 to D3'}, {'id': 'OG004', 'title': 'Ibrexafungerp 300-mg D1 to D3', 'description': '300 mg BID D1 to D3'}, {'id': 'OG005', 'title': 'Fluconazole', 'description': '150 mg QD D1 only'}], 'classes': [{'categories': [{'title': 'Clinical cure', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}, {'title': 'Clinical failure', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8-12 days', 'description': 'Measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Co-occurrence of Clinical and Mycological Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp 750-mg', 'description': '750 mg QD D1 only'}, {'id': 'OG001', 'title': 'Ibrexafungerp 300-mg', 'description': '300 mg BID D1 only'}, {'id': 'OG002', 'title': 'Ibrexafungerp 450-mg', 'description': '450 mg BID D1 only'}, {'id': 'OG003', 'title': 'Ibrexafungerp 150-mg', 'description': '150 mg BID D1 to D3'}, {'id': 'OG004', 'title': 'Ibrexafungerp 300-mg D1 to D3', 'description': '300 mg BID D1 to D3'}, {'id': 'OG005', 'title': 'Fluconazole', 'description': '150 mg QD D1 only'}], 'classes': [{'categories': [{'title': 'Clinical cure and Mycological Eradication', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}, {'title': 'Clinical failure and/or mycological persistence', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '29 days', 'description': 'The percentage of subjects with both clinical cure and mycological eradication (negative fungal culture) the Test-of cure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp 750-mg', 'description': '750 mg QD D1 only'}, {'id': 'OG001', 'title': 'Ibrexafungerp 300-mg', 'description': '300 mg BID D1 only'}, {'id': 'OG002', 'title': 'Ibrexafungerp 450-mg', 'description': '450 mg BID D1 only'}, {'id': 'OG003', 'title': 'Ibrexafungerp 150-mg', 'description': '150 mg BID D1 to D3'}, {'id': 'OG004', 'title': 'Ibrexafungerp 300-mg D1 to D3', 'description': '300 mg BID D1 to D3'}, {'id': 'OG005', 'title': 'Fluconazole', 'description': '150 mg QD D1 only'}], 'classes': [{'categories': [{'title': 'Treatment related Treatment-emergent adverse event', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}, {'title': 'No Treatment related Treatment-emergent adverse event', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 29 days', 'description': 'The number of subjects with treatment related adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ibrexafungerp 750-mg', 'description': '750 mg QD for 1 day only'}, {'id': 'FG001', 'title': 'Ibrexafungerp 300-mg', 'description': '300 mg BID for 1 day only'}, {'id': 'FG002', 'title': 'Ibrexafungerp 450-mg', 'description': '450 mg BID for 1 day only'}, {'id': 'FG003', 'title': 'Ibrexafungerp 150-mg', 'description': '150 mg BID for 3 days'}, {'id': 'FG004', 'title': 'Ibrexafungerp 300-mg (3 Days)', 'description': '300 mg BID for 3 days'}, {'id': 'FG005', 'title': 'Fluconazole', 'description': '150 mg QD for 1 day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '32'}, {'groupId': 'FG004', 'numSubjects': '32'}, {'groupId': 'FG005', 'numSubjects': '32'}]}, {'type': 'Subjects Discontinued', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '27'}, {'groupId': 'FG005', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '186', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Ibrexafungerp 750-mg', 'description': '750 mg QD for 1 day only'}, {'id': 'BG001', 'title': 'Ibrexafungerp 300-mg', 'description': '300 mg BID for 1 day only'}, {'id': 'BG002', 'title': 'Ibrexafungerp 450-mg', 'description': '450 mg BID for 1 day only'}, {'id': 'BG003', 'title': 'Ibrexafungerp 150-mg', 'description': '150 mg BID for 3 days'}, {'id': 'BG004', 'title': 'Ibrexafungerp 300-mg (3 Days)', 'description': '300 mg BID for 3 days'}, {'id': 'BG005', 'title': 'Fluconazole', 'description': '150 mg QD for 1 day'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.6', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '34.4', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '34.5', 'spread': '9.8', 'groupId': 'BG002'}, {'value': '33.3', 'spread': '10.5', 'groupId': 'BG003'}, {'value': '32.0', 'spread': '8.5', 'groupId': 'BG004'}, {'value': '33.8', 'spread': '10.1', 'groupId': 'BG005'}, {'value': '33.7', 'spread': '10.4', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '186', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '56', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '130', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 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'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-04T15:05', 'hasProtocol': True}, {'date': '2018-06-06', 'size': 3005519, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-04T15:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, double-blind, double-dummy, active-controlled, dose-finding'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'dispFirstSubmitDate': '2020-10-20', 'completionDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-11', 'studyFirstSubmitDate': '2017-07-14', 'dispFirstSubmitQcDate': '2021-08-11', 'resultsFirstSubmitDate': '2021-06-30', 'studyFirstSubmitQcDate': '2017-08-16', 'dispFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-11', 'studyFirstPostDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of Treatment Emergent Adverse Events', 'timeFrame': 'up to 29 days', 'description': 'The number of subjects with treatment related adverse events'}], 'primaryOutcomes': [{'measure': 'Clinical Cure (Complete Resolution of Signs and Symptoms)', 'timeFrame': '8-12 days', 'description': 'Measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit'}], 'secondaryOutcomes': [{'measure': 'Co-occurrence of Clinical and Mycological Cure', 'timeFrame': '29 days', 'description': 'The percentage of subjects with both clinical cure and mycological eradication (negative fungal culture) the Test-of cure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Candida Vulvovaginitis']}, 'referencesModule': {'references': [{'pmid': '34555149', 'type': 'DERIVED', 'citation': 'Nyirjesy P, Schwebke JR, Angulo DA, Harriott IA, Azie NE, Sobel JD. Phase 2 Randomized Study of Oral Ibrexafungerp Versus Fluconazole in Vulvovaginal Candidiasis. Clin Infect Dis. 2022 Jul 6;74(12):2129-2135. doi: 10.1093/cid/ciab841.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per treatment group) will be enrolled and randomized into the study.', 'detailedDescription': 'This is a Phase 2, multicenter, randomized, double-blind, double-dummy, active-controlled, dose-ranging study of female subjects with moderate to severe Acute Vulvovaginal Candidiasis. Subjects will be randomized to either the investigational arm (SCY-078) with 5 different dose regiments ranging from 1 to 3 days of treatment or to the active-control arm (fluconazole) for 1 day of treatment. After randomization subjects may be seen on study Day 3 (on site visit for PK subjects) , Day 10 (±2,) and Day 25 (+4).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Subject is a female of at least 18 years of age\n2. Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)\n\nKey Exclusion Criteria:\n\n1. Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)\n2. Need for systemic and/or topical (vaginal) antifungal treatment, including prescription or over-the-counter products during the study and treatment for VVC 28 days prior to randomization\n3. Subject is actively menstruating at the time of the Baseline visit.\n4. Subject has uncontrolled diabetes mellitus.\n5. Subject has a vaginal sample with pH \\>4.5.\n6. Subject has a history of or an active cervical/vaginal cancer.'}, 'identificationModule': {'nctId': 'NCT03253094', 'acronym': 'DOVE', 'briefTitle': 'Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Scynexis, Inc.'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Dose-Finding Study to Compare the Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis', 'orgStudyIdInfo': {'id': 'SCY-078-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fluconazole', 'description': '150 mg/day for 1 day', 'interventionNames': ['Drug: Fluconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Ibrexafungerp 750mg', 'description': '750mg QD for 1 day only', 'interventionNames': ['Drug: SCY-078']}, {'type': 'EXPERIMENTAL', 'label': 'Ibrexafungerp 300mg', 'description': '300mg BID for 1 day only', 'interventionNames': ['Drug: SCY-078']}, {'type': 'EXPERIMENTAL', 'label': 'Ibrexafungerp 450mg', 'description': '450mg BID for 1 day only', 'interventionNames': ['Drug: SCY-078']}, {'type': 'EXPERIMENTAL', 'label': 'Ibrexafungerp 150mg', 'description': '150mg BID for 3 days', 'interventionNames': ['Drug: SCY-078']}, {'type': 'EXPERIMENTAL', 'label': 'Ibrexafungerp 300mg D1-D3', 'description': '300mg BID for 3 days', 'interventionNames': ['Drug: SCY-078']}], 'interventions': [{'name': 'Fluconazole', 'type': 'DRUG', 'otherNames': ['Diflucan, Azole antifungal'], 'description': 'Oral Antifungal comparator', 'armGroupLabels': ['Fluconazole']}, {'name': 'SCY-078', 'type': 'DRUG', 'otherNames': ['Ibrexafungerp'], 'description': 'Investigational Antifungal', 'armGroupLabels': ['Ibrexafungerp 150mg', 'Ibrexafungerp 300mg', 'Ibrexafungerp 300mg D1-D3', 'Ibrexafungerp 450mg', 'Ibrexafungerp 750mg']}]}, 'contactsLocationsModule': 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'WR-Medical Research Center of Memphis, LLC', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Tmc Life Research, Inc.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials of Texas, Inc.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Women's Health, Research, Gynecology", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'David Angulo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Scynexis, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scynexis, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}