Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-01 @ 3:53 PM
Study NCT ID:
NCT02515656
Status:
COMPLETED
Last Update Posted:
2019-01-22
First Post:
2015-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014627', 'term': 'Vaginitis'}], 'ancestors': [{'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': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C006119', 'term': 'acetarsol, dimethicone, neomycin, nystatin, polymyxin drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+33 (0)1 46 15 29 00', 'title': 'Director of Medical Affairs', 'organization': 'Laboratoire Innotech International'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '22 days', 'eventGroups': [{'id': 'EG000', 'title': 'POLYGYNAX®', 'description': 'Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules\n\nPOLYGYNAX®', 'otherNumAtRisk': 325, 'deathsNumAtRisk': 325, 'otherNumAffected': 18, 'seriousNumAtRisk': 325, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Miconazole + Placebo', 'description': 'Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules\n\nGYNODAKTARIN®\n\nPlacebo', 'otherNumAtRisk': 328, 'deathsNumAtRisk': 328, 'otherNumAffected': 5, 'seriousNumAtRisk': 328, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 328, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Patient pregnant exposed to study medications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 328, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'POLYGYNAX®', 'description': 'Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules\n\nPOLYGYNAX®'}, {'id': 'OG001', 'title': 'Miconazole + Placebo', 'description': 'Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules\n\nGYNODAKTARIN®\n\nPlacebo'}], 'classes': [{'categories': [{'title': 'Success', 'measurements': [{'value': '275', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}, {'title': 'Failure', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '15 days after first treatment administration', 'description': '* Success is defined by resolution (return to patient\'s usual gynaecological conditions, i.e. before the episode which warranted inclusion in the study) OR substantial improvement of clinical signs of infectious vaginitis (i.e. abnormal vaginal discharge), and/or vaginal symptoms (vaginal burning and/or vaginal pain, and/or vaginal irritation).\n* Failure is defined by persistence or worsening of symptoms and clinical signs or requirement of an alternative or specific treatment.\n\nNot considered as "Treatment Failure":\n\n* The need to initiate a specific treatment because of a Sexually Transmitted Infection (STI) (trichomoniasis; gonococcal and chlamydial infections) detected from the vaginal sample at Visit 1 / D1.\n* Patients presenting with only vulvar complaints not considered as related to infectious vaginitis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'POLYGYNAX®', 'description': 'Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules\n\nPOLYGYNAX®'}, {'id': 'OG001', 'title': 'Miconazole + Placebo', 'description': 'Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules\n\nGYNODAKTARIN®\n\nPlacebo'}], 'classes': [{'title': 'Vaginal discharge absolute change', 'categories': [{'measurements': [{'value': '31.43', 'groupId': 'OG000', 'lowerLimit': '29.94', 'upperLimit': '32.91'}, {'value': '29.54', 'groupId': 'OG001', 'lowerLimit': '28.07', 'upperLimit': '31.01'}]}]}, {'title': 'Vaginal burning absolute change', 'categories': [{'measurements': [{'value': '27.89', 'groupId': 'OG000', 'lowerLimit': '26.66', 'upperLimit': '29.12'}, {'value': '27.03', 'groupId': 'OG001', 'lowerLimit': '25.81', 'upperLimit': '28.25'}]}]}, {'title': 'Vaginal pain absolute change', 'categories': [{'measurements': [{'value': '16.93', 'groupId': 'OG000', 'lowerLimit': '15.86', 'upperLimit': '18.01'}, {'value': '17.17', 'groupId': 'OG001', 'lowerLimit': '16.10', 'upperLimit': '18.24'}]}]}, {'title': 'Vaginal irritation absolute change', 'categories': [{'measurements': [{'value': '29.37', 'groupId': 'OG000', 'lowerLimit': '28.06', 'upperLimit': '30.67'}, {'value': '28.79', 'groupId': 'OG001', 'lowerLimit': '27.51', 'upperLimit': '30.08'}]}]}, {'title': 'Vaginal combined clinical symptoms score absolute', 'categories': [{'measurements': [{'value': '28.96', 'groupId': 'OG000', 'lowerLimit': '26.79', 'upperLimit': '31.14'}, {'value': '28.20', 'groupId': 'OG001', 'lowerLimit': '26.04', 'upperLimit': '30.35'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'during 14 days after first treatment intake', 'description': 'This outcome was evaluated using a Visual Analogue Scale (VAS) completed by the patient.\n\nThe scale measured the level of each vaginal symptom experienced during the day (vaginal discharge, vaginal burning, vaginal pain and vaginal irritation).\n\nScale ranges = 0 to 100 0=none symptom 100=maximum intensity of symptom Time points used in the calculation= D1 to D14', 'unitOfMeasure': 'mm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Change in Vaginal Discharge Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'POLYGYNAX®', 'description': 'Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules\n\nPOLYGYNAX®'}, {'id': 'OG001', 'title': 'Miconazole + Placebo', 'description': 'Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules\n\nGYNODAKTARIN®\n\nPlacebo'}], 'classes': [{'title': 'Leucorrhoea score change - Deterioration', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Leucorrhoea score change - No change', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Leucorrhoea score change - Improvement', 'categories': [{'measurements': [{'value': '280', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '15 days after first treatment administration', 'description': 'The vaginal discharge is assessed by the investigator by using a score:\n\n0=absent\n\n1. mild: insufficient for speculum collection\n2. moderate: sufficient for speculum collection\n3. abundant: visible at the introitus even before speculum introduction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Clinical Treatment Efficacy (Success/Failure) Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Study Visit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'POLYGYNAX®', 'description': 'Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules\n\nPOLYGYNAX®'}, {'id': 'OG001', 'title': 'Miconazole + Placebo', 'description': 'Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules\n\nGYNODAKTARIN®\n\nPlacebo'}], 'classes': [{'title': 'Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '252', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}]}, {'title': 'Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '22 days after first treatment administration', 'description': 'Success and Failure (same definition as the primary outcome measure)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 5 and 6 missing values respectively in Polygynax and Miconazole + placebo arms.'}, {'type': 'SECONDARY', 'title': "Investigator's Global Satisfaction", 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'POLYGYNAX®', 'description': 'Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules\n\nPOLYGYNAX®'}, {'id': 'OG001', 'title': 'Miconazole + Placebo', 'description': 'Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules\n\nGYNODAKTARIN®\n\nPlacebo'}], 'classes': [{'categories': [{'title': 'Very good - Good', 'measurements': [{'value': '265', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}, {'title': 'Somewhat good - Somewhat bad', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Bad - Very bad', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '15 days after first administration', 'description': 'The investigator filled the satisfaction questionnaire during the end of treatment visit.\n\nSix ratings are available: Very Bad, Bad, Somewhat Bad, Somewhat Good, Good and Very Good.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Patient's Global Satisfaction", 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'POLYGYNAX®', 'description': 'Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules\n\nPOLYGYNAX®'}, {'id': 'OG001', 'title': 'Miconazole + Placebo', 'description': 'Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules\n\nGYNODAKTARIN®\n\nPlacebo'}], 'classes': [{'categories': [{'title': 'Very good - Good', 'measurements': [{'value': '239', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}, {'title': 'Somewhat good - Somewhat bad', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}, {'title': 'Bad - Very bad', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '15 days after first administration', 'description': "The patient filled the satisfaction questionnaire on her patient's diary at home the eve of the End of Treatment Visit.\n\nSix ratings are available: Very Bad, Bad, Somewhat Bad, Somewhat Good, Good and Very Good.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 10 and 11 missing values respectively in Polygynax and Miconazole + placebo arms.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'POLYGYNAX®', 'description': 'Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules\n\nPOLYGYNAX®'}, {'id': 'FG001', 'title': 'Miconazole + Placebo', 'description': 'Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules\n\nGYNODAKTARIN®\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '326'}, {'groupId': 'FG001', 'numSubjects': '332'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '302'}, {'groupId': 'FG001', 'numSubjects': '309'}]}, {'type': 'Per Protocol Set (PPS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '277'}, {'groupId': 'FG001', 'numSubjects': '275'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '325'}, {'groupId': 'FG001', 'numSubjects': '328'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '261'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '71'}]}]}], 'preAssignmentDetails': '3 patients who signed an Informed Consent Form (ICF) were screen failed and were not randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'BG000'}, {'value': '309', 'groupId': 'BG001'}, {'value': '611', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'POLYGYNAX®', 'description': 'Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules\n\nPOLYGYNAX®'}, {'id': 'BG001', 'title': 'Miconazole + Placebo', 'description': 'Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules\n\nGYNODAKTARIN®\n\nPlacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.70', 'spread': '10.13', 'groupId': 'BG000'}, {'value': '33.73', 'spread': '10.07', 'groupId': 'BG001'}, {'value': '34.21', 'spread': '10.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '302', 'groupId': 'BG000'}, {'value': '309', 'groupId': 'BG001'}, {'value': '611', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 661}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2015-07-29', 'resultsFirstSubmitDate': '2017-09-21', 'studyFirstSubmitQcDate': '2015-08-01', 'lastUpdatePostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-13', 'studyFirstPostDateStruct': {'date': '2015-08-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit", 'timeFrame': '15 days after first treatment administration', 'description': '* Success is defined by resolution (return to patient\'s usual gynaecological conditions, i.e. before the episode which warranted inclusion in the study) OR substantial improvement of clinical signs of infectious vaginitis (i.e. abnormal vaginal discharge), and/or vaginal symptoms (vaginal burning and/or vaginal pain, and/or vaginal irritation).\n* Failure is defined by persistence or worsening of symptoms and clinical signs or requirement of an alternative or specific treatment.\n\nNot considered as "Treatment Failure":\n\n* The need to initiate a specific treatment because of a Sexually Transmitted Infection (STI) (trichomoniasis; gonococcal and chlamydial infections) detected from the vaginal sample at Visit 1 / D1.\n* Patients presenting with only vulvar complaints not considered as related to infectious vaginitis.'}], 'secondaryOutcomes': [{'measure': 'Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary', 'timeFrame': 'during 14 days after first treatment intake', 'description': 'This outcome was evaluated using a Visual Analogue Scale (VAS) completed by the patient.\n\nThe scale measured the level of each vaginal symptom experienced during the day (vaginal discharge, vaginal burning, vaginal pain and vaginal irritation).\n\nScale ranges = 0 to 100 0=none symptom 100=maximum intensity of symptom Time points used in the calculation= D1 to D14'}, {'measure': 'Number of Patients With Change in Vaginal Discharge Assessed by the Investigator', 'timeFrame': '15 days after first treatment administration', 'description': 'The vaginal discharge is assessed by the investigator by using a score:\n\n0=absent\n\n1. mild: insufficient for speculum collection\n2. moderate: sufficient for speculum collection\n3. abundant: visible at the introitus even before speculum introduction.'}, {'measure': "Clinical Treatment Efficacy (Success/Failure) Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Study Visit", 'timeFrame': '22 days after first treatment administration', 'description': 'Success and Failure (same definition as the primary outcome measure)'}, {'measure': "Investigator's Global Satisfaction", 'timeFrame': '15 days after first administration', 'description': 'The investigator filled the satisfaction questionnaire during the end of treatment visit.\n\nSix ratings are available: Very Bad, Bad, Somewhat Bad, Somewhat Good, Good and Very Good.'}, {'measure': "Patient's Global Satisfaction", 'timeFrame': '15 days after first administration', 'description': "The patient filled the satisfaction questionnaire on her patient's diary at home the eve of the End of Treatment Visit.\n\nSix ratings are available: Very Bad, Bad, Somewhat Bad, Somewhat Good, Good and Very Good."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Vaginitis']}, 'descriptionModule': {'briefSummary': 'POLYGYNAX® is a broad spectrum combination of nystatin, neomycin and polymixin B indicated for the local treatment of vaginitis due to sensitive germs and treatment of non specific vaginitis of adults. POLYGYNAX® has been marketed in France since 1969.\n\nNevertheless, despite the well established use of POLYGYNAX®, there is no clinical study supporting the interest of the combination of antifungal and antibiotics agents versus antifungal agent alone.\n\nThe aim of this project is to demonstrate that POLYGYNAX® is more effective than miconazole in the treatment of women experiencing symptoms of infectious vaginitis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with an abnormal vaginal discharge associated with one (or more) functional vaginal complaints: vaginal burning and/or vaginal pain and/or vaginal irritation clinically evoking an infectious vaginitis:\n\n * bacterial vaginitis\n * non-specific vaginitis (atypical symptoms)\n * mixed vaginitis (i.e. suprainfected fungal vaginitis) and able to receive an empirical local treatment\n\nExclusion Criteria:\n\n1. Recurrent patient; i.e. a patient who has had at least 4 episodes of infectious vaginitis in the 12 months prior to inclusion\n2. Vaginal infection justifying systemic therapy\n3. History of atrophic vaginitis or suspected atrophic vaginitis at inclusion\n4. Patient presenting with signs of genital herpes or signs of non-infectious vulvar pathology (vulvodynia, psoriasis, eczema, lichen sclerosus, lichen planus, contact dermatitis, candida intertrigo, vulval intraepithelial neoplasia (VIN))\n5. Patient with current Sexually Transmitted Infection (STI) and/or patients with clinical suspicion of STI\n6. Disease or concomitant treatment that could cause decreased immunity (i.e. diabetes mellitus, corticosteroids treatments)\n7. Systemic anti-infective treatment (antibiotic, antifungal) within two weeks prior to inclusion\n8. Patient menstruating or patient with menometrorrhagia due to hormonal imbalance at the time of inclusion\n9. Pregnant or lactating women or delivery within last 1 month'}, 'identificationModule': {'nctId': 'NCT02515656', 'acronym': 'PRISM', 'briefTitle': 'Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoire Innotech International'}, 'officialTitle': 'Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis International, Multicentre, Randomised, Double-blind, Parallel Group Study, Comparative Versus Miconazole', 'orgStudyIdInfo': {'id': 'PGX 401-11'}, 'secondaryIdInfos': [{'id': '2014-001759-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'POLYGYNAX®', 'description': 'Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules', 'interventionNames': ['Drug: POLYGYNAX®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'miconazole + placebo', 'description': 'Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules', 'interventionNames': ['Drug: GYNODAKTARIN®', 'Drug: Placebo']}], 'interventions': [{'name': 'POLYGYNAX®', 'type': 'DRUG', 'armGroupLabels': ['POLYGYNAX®']}, {'name': 'GYNODAKTARIN®', 'type': 'DRUG', 'armGroupLabels': ['miconazole + placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['miconazole + placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Prague', 'country': 'Czechia', 'facility': 'TURKOVA', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '69009', 'city': 'Lyon', 'country': 'France', 'facility': 'PERCEVAL', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'MARICIC', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Martin', 'country': 'Slovakia', 'facility': 'GATOVA', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}], 'overallOfficials': [{'name': 'Jean-Marc BOHBOT, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Alfred Fournier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoire Innotech International', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'International Clinical Trials Association', 'class': 'OTHER'}, {'name': 'Venn Life Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}