Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT03562156
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2018-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
Sponsor:
Organization:
Raw JSON
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If multi-center publication is not issued within 18 months of study completion and database lock at all sites, sponsor has 30 days from receipt to review institution's and/or investigator's communication and can require removal of confidential information other than study data and/or delay release of institution's and/or investigator's communication for 60 days.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 through Week 48', 'description': 'The safety population was defined as all randomized subjects who received at least 1 dose of investigational product, which was not administered until Day 1. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. Adverse event data were not collected during the induction phase.', 'eventGroups': [{'id': 'EG000', 'title': 'Oteseconazole (VT-1161)', 'description': '1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks', 'otherNumAtRisk': 217, 'deathsNumAtRisk': 217, 'otherNumAffected': 129, 'seriousNumAtRisk': 217, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo', 'description': '1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks', 'otherNumAtRisk': 109, 'deathsNumAtRisk': 109, 'otherNumAffected': 63, 'seriousNumAtRisk': 109, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 37, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlamydial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vulvitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vulvovaginal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tubo-ovarian abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal haemmorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Limb traumatic amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With 1 or More Culture-Verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-Treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oteseconazole (VT-1161)', 'description': '1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '42.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Maintenance phase (post-randomization through Week 48)', 'description': 'The primary efficacy outcome measure was the percentage of subjects with 1 or more culture-verified acute VVC episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population. An acute VVC episode during the maintenance phase (considered a recurrent episode) was defined as a positive fungal culture for Candida species and a clinical signs and symptoms score of ≥3. To calculate the signs and symptoms score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with a higher score indicating a worse outcome.\n\n0 = none (complete absence of any sign or symptom), 1 = mild (slight), 2 = moderate (definitely present), 3 = severe (marked, intense)', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ITT population which included all randomized subjects. Missing values were imputed with multiple imputation using the following auxiliary information: region, treatment, baseline body mass index, baseline age, ethnicity, and visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oteseconazole (VT-1161)', 'description': '1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': '1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '217'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '182'}, {'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '18'}]}]}], 'preAssignmentDetails': 'A total of 438 subjects were enrolled in a 2-week Induction Phase after providing consent. During the Induction Phase, subjects received 3 sequential 150mg of fluconazole administered 72 hours apart. Subjects whose presenting acute VVC (vulvovaginal candidiasis) episode resolved during the Induction Phase (a total of 326) entered a 48-week Maintenance Phase comprised of a 12-week treatment period and a 36-week follow-up period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oteseconazole (VT-1161)', 'description': '1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': '1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '34', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '34', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '217', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-01', 'size': 5175659, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-12T13:58', 'hasProtocol': True}, {'date': '2020-07-25', 'size': 5373736, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-12T13:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 438}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2018-06-01', 'resultsFirstSubmitDate': '2021-10-19', 'studyFirstSubmitQcDate': '2018-06-18', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-06', 'studyFirstPostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With 1 or More Culture-Verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-Treat Population', 'timeFrame': 'Maintenance phase (post-randomization through Week 48)', 'description': 'The primary efficacy outcome measure was the percentage of subjects with 1 or more culture-verified acute VVC episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population. An acute VVC episode during the maintenance phase (considered a recurrent episode) was defined as a positive fungal culture for Candida species and a clinical signs and symptoms score of ≥3. To calculate the signs and symptoms score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with a higher score indicating a worse outcome.\n\n0 = none (complete absence of any sign or symptom), 1 = mild (slight), 2 = moderate (definitely present), 3 = severe (marked, intense)'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recurrent Vulvovaginal Candidiasis']}, 'referencesModule': {'references': [{'pmid': '38319878', 'type': 'DERIVED', 'citation': 'Sobel JD, Donders G, Degenhardt T, Person K, Curelop S, Ghannoum M, Brand SR. Efficacy and Safety of Oteseconazole in Recurrent Vulvovaginal Candidiasis. NEJM Evid. 2022 Aug;1(8):EVIDoa2100055. doi: 10.1056/EVIDoa2100055. Epub 2022 Jul 26.'}, {'pmid': '36396498', 'type': 'DERIVED', 'citation': 'Vanreppelen G, Nysten J, Baldewijns S, Sillen M, Donders G, Van Dijck P. Oteseconazole (VIVOJA) for prevention of recurrent vulvovaginal candidiasis. Trends Pharmacol Sci. 2023 Jan;44(1):64-65. doi: 10.1016/j.tips.2022.10.004. Epub 2022 Nov 14. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute VVC in the past 12 months. Several properties of oteseconazole (VT-1161) suggest that it might be a safer and more effective treatment for RVVC than other oral anti-fungal medicines.\n\nThis study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the treatment of RVVC and consists of 2 parts. The first part of the study is a 2-week period for the treatment of the patient's current VVC episode with 3 150mg doses of fluconazole. The 2nd part consists of 12 weeks, when the patient will take either oteseconazole (VT-1161) 150 mg or a placebo (according to a random assignment), and then a 36-week follow-up period.\n\nIn addition, at participating sites, an amendment to the study allows US patients who complete the initial 48 weeks without experiencing a confirmed RVVC episode to continue in a 48-week observational extension period designed to evaluate the continued effectiveness of oteseconazole (VT-1161).\n\nThis study is identical to VMT-VT-1161-CL-012 (NCT03561701)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* 3 or more episodes of acute VVC in the past 12 months\n* Positive KOH or Gram stain\n* Total vulvovaginal signs and symptoms score of ≥3 at screening visit\n* Total vulvovaginal signs and symptoms score of \\<3 at baseline visit\n* Must be able to swallow pills\n\nKey Exclusion Criteria:\n\n* Presence or a history of another vaginal or vulvar condition(s)\n* Evidence of major organ system disease\n* History of cervical cancer\n* Poorly controlled diabetes mellitus\n* Pregnant\n* Recent use of topical or systemic antifungal or antibacterial drugs\n* Recent use of immunosuppressive or systemic corticosteroid therapies'}, 'identificationModule': {'nctId': 'NCT03562156', 'acronym': 'VIOLET', 'briefTitle': 'A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mycovia Pharmaceuticals Inc.'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oteseconazole (VT-1161) Oral Capsules in the Treatment of Subjects With Recurrent Vulvovaginal Candidiasis', 'orgStudyIdInfo': {'id': 'VMT-VT-1161-CL-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oteseconazole (VT-1161) 150mg capsule', 'description': 'Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks', 'interventionNames': ['Drug: Oteseconazole (VT-1161)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo capsule', 'description': 'Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Oteseconazole (VT-1161)', 'type': 'DRUG', 'description': 'Oteseconazole (VT-1161) 150mg capsule', 'armGroupLabels': ['Oteseconazole (VT-1161) 150mg capsule']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'matching placebo capsule', 'armGroupLabels': ['Placebo capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': '31123', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92111', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': '31108', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33319', 'city': 'Lauderdale Lakes', 'state': 'Florida', 'country': 'United States', 'facility': '31139', 'geoPoint': {'lat': 26.16647, 'lon': -80.20838}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': '31143', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33414', 'city': 'Wellington', 'state': 'Florida', 'country': 'United States', 'facility': '31106', 'geoPoint': {'lat': 26.65868, 'lon': -80.24144}}, {'zip': '30095', 'city': 'Norcross', 'state': 'Georgia', 'country': 'United States', 'facility': '31111', 'geoPoint': {'lat': 33.94121, 'lon': -84.21353}}, {'zip': '70433', 'city': 'Covington', 'state': 'Louisiana', 'country': 'United States', 'facility': '31146', 'geoPoint': {'lat': 30.47549, 'lon': -90.10042}}, {'zip': '70001', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': '31107', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': '31105', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '02720', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': '31147', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '89123', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': '31118', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': '31103', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08648', 'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'facility': '31114', 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'zip': '11777', 'city': 'Port Jefferson', 'state': 'New York', 'country': 'United States', 'facility': '31142', 'geoPoint': {'lat': 40.94649, 'lon': -73.06927}}, {'zip': '14224', 'city': 'West Seneca', 'state': 'New York', 'country': 'United States', 'facility': '31127', 'geoPoint': {'lat': 42.85006, 'lon': -78.79975}}, {'zip': '27408', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': '31132', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', 'facility': '31116', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': '31144', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': '31145', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45005', 'city': 'Franklin', 'state': 'Ohio', 'country': 'United States', 'facility': '31125', 'geoPoint': {'lat': 39.55895, 'lon': -84.30411}}, {'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': '31134', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37620', 'city': 'Bristol', 'state': 'Tennessee', 'country': 'United States', 'facility': '31120', 'geoPoint': {'lat': 36.59511, 'lon': -82.18874}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': '31102', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84020', 'city': 'Draper', 'state': 'Utah', 'country': 'United States', 'facility': '31117', 'geoPoint': {'lat': 40.52467, 'lon': -111.86382}}, {'zip': '23225', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': '31113', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mycovia Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}