Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-24 @ 1:15 AM
Study NCT ID:
NCT02308033
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2014-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multi-Center Study of New Medications to Treat Vaginal Infections
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': 'D008795', 'term': 'Metronidazole'}, {'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@curatek.com', 'phone': '847-806-7680', 'title': 'Vice President', 'organization': 'Curatek Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Investigators have the right to disclose and publish results of the Study conducted by them; provided that, in order to protect any Sponsor confidential information, Investigator shall submit to Sponsor manuscripts at least 30 days before submission for publication or 10 days before public presentation. After that time, Investigator is free to submit the manuscript for publication or deliver the presentation, provided Investigator removes any confidential information as directed by Sponsor', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected over the entire course of the study (up to 30 days after beginning treatment).', 'description': 'Adverse events were collected through direct questioning at each post-baseline visit, by participant diaries, and by spontaneous reporting. The safety population includes all participants randomized to treatment and administered at least one dose of study drug, and includes subjects who had a normal gram stain Nugent score at the baseline visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Metronidazole Vaginal Gel', 'description': 'One applicator full at bedtime\n\nMetronidazole', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 25, 'seriousNumAtRisk': 96, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Gel Vehicle', 'description': 'One applicator full at bedtime\n\nGel vehicle', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 10, 'seriousNumAtRisk': 97, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vulvovaginal pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metronidazole Vaginal Gel', 'description': 'One applicator full at bedtime\n\nMetronidazole'}, {'id': 'OG001', 'title': 'Gel Vehicle', 'description': 'One applicator full at bedtime\n\nGel vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7-14 days after beginning treatment', 'description': 'The percentage of participants with clinical cure in each arm was compared. Clinical cure of bacterial vaginosis is defined as 1. discharge has returned to normal/physiologic, 2. the whiff test is negative for any amine "fishy" odor, 3. the saline wet mount is \\<20% clue cells', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication)'}, {'type': 'SECONDARY', 'title': 'Improvement of BV Clue Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metronidazole Vaginal Gel', 'description': 'One applicator full at bedtime\n\nMetronidazole'}, {'id': 'OG001', 'title': 'Gel Vehicle', 'description': 'One applicator full at bedtime\n\nGel vehicle'}], 'classes': [{'categories': [{'title': 'Clue cells absent', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': 'Clue cells present', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}, {'title': 'Data missing', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7-14 days after beginning treatment', 'description': 'Clue cells on wet mount were assessed and categorized as absent (\\<20%) or present (\\>=20%). Absence of clue cells is associated with improvement. The comparison was for percentage between arms for clue cells absent (\\<20%).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication)'}, {'type': 'SECONDARY', 'title': 'Microbiologic Improvement/Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metronidazole Vaginal Gel', 'description': 'One applicator full at bedtime\n\nMetronidazole'}, {'id': 'OG001', 'title': 'Gel Vehicle', 'description': 'One applicator full at bedtime\n\nGel vehicle'}], 'classes': [{'categories': [{'title': 'Normal Nugent score', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Intermediate Nugent score', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'BV Nugent score', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}, {'title': 'Not taken', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of normal Nugent scores at 7-14 days', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7-14 days after beginning treatment', 'description': 'For bacterial vaginosis (BV), Gram stain Nugent scores are catergized as normal (0 to 3), intermediate (4 to 6) or BV (7 to 10). Normal scores are associated with BV microbiologic cure. The percentage of participants with normal scores were compared between treatments.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metronidazole Vaginal Gel', 'description': 'One applicator full at bedtime\n\nMetronidazole'}, {'id': 'OG001', 'title': 'Gel Vehicle', 'description': 'One applicator full at bedtime\n\nGel vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.034', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of the number of subjects whose reported their symptoms completely resolved', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7-14 days after beginning treatment', 'description': 'Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metronidazole Vaginal Gel', 'description': 'One applicator full at bedtime\n\nMetronidazole'}, {'id': 'OG001', 'title': 'Gel Vehicle', 'description': 'One applicator full at bedtime\n\nGel vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Any time during study participation (up to 30 days)', 'description': 'Adverse events were collected at study visits, from subject diaries and from spontaneous reports', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all subjects randomized to treatment and administered at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metronidazole Vaginal Gel', 'description': 'One applicator full at bedtime\n\nMetronidazole'}, {'id': 'FG001', 'title': 'Gel Vehicle', 'description': 'One applicator full at bedtime\n\nGel vehicle'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Normal Gram stain at Baseline', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Positive for STD at Baseline', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Metronidazole Vaginal Gel', 'description': 'One applicator full at bedtime\n\nMetronidazole'}, {'id': 'BG001', 'title': 'Gel Vehicle', 'description': 'One applicator full at bedtime\n\nGel vehicle'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.1', 'spread': '8.76', 'groupId': 'BG000'}, {'value': '35.8', 'spread': '10.48', 'groupId': 'BG001'}, {'value': '34.5', 'spread': '9.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', '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': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'modified intent-to-treat (mITT) population includes all subjects randomized to treatment and administered at least one dose of study drug. In addition, subjects must have a Nugent score of 4 or more on Baseline visit Gram stain slide.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-03-12', 'size': 2839255, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-06-18T17:27', 'hasProtocol': True}, {'date': '2018-05-01', 'size': 655070, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-06-18T17:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'dispFirstSubmitDate': '2018-06-26', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-09', 'studyFirstSubmitDate': '2014-12-01', 'dispFirstSubmitQcDate': '2018-06-27', 'resultsFirstSubmitDate': '2020-06-18', 'studyFirstSubmitQcDate': '2014-12-02', 'dispFirstPostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-09', 'studyFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit', 'timeFrame': '7-14 days after beginning treatment', 'description': 'The percentage of participants with clinical cure in each arm was compared. Clinical cure of bacterial vaginosis is defined as 1. discharge has returned to normal/physiologic, 2. the whiff test is negative for any amine "fishy" odor, 3. the saline wet mount is \\<20% clue cells'}], 'secondaryOutcomes': [{'measure': 'Improvement of BV Clue Cells', 'timeFrame': '7-14 days after beginning treatment', 'description': 'Clue cells on wet mount were assessed and categorized as absent (\\<20%) or present (\\>=20%). Absence of clue cells is associated with improvement. The comparison was for percentage between arms for clue cells absent (\\<20%).'}, {'measure': 'Microbiologic Improvement/Cure', 'timeFrame': '7-14 days after beginning treatment', 'description': 'For bacterial vaginosis (BV), Gram stain Nugent scores are catergized as normal (0 to 3), intermediate (4 to 6) or BV (7 to 10). Normal scores are associated with BV microbiologic cure. The percentage of participants with normal scores were compared between treatments.'}, {'measure': 'Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit', 'timeFrame': '7-14 days after beginning treatment', 'description': 'Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events', 'timeFrame': 'Any time during study participation (up to 30 days)', 'description': 'Adverse events were collected at study visits, from subject diaries and from spontaneous reports'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vaginal Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the treatment of vaginal infections.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A clinical diagnosis of vaginal infection that is confirmed by laboratory testing and:\n* Capable of providing written informed consent or assent\n* Currently not menstruating and not anticipating menses during treatment\n* If heterosexually active, subject must be post-menopausal for ≥ 1 year, surgically sterile, or practicing an acceptable form of birth control\n* Negative pregnancy test\n* Other criteria as identified in the protocol\n\nExclusion Criteria:\n\n* Other infectious causes of vulvovaginitis\n* Subject has recently used, or is expected to require the concomitant use of prohibited medications/products\n* Nursing mother\n* Use of any investigational drug within 30 days of enrollment\n* History of hypersensitivity to any ingredient/component of the formulations\n* Other criteria as identified in the protocol'}, 'identificationModule': {'nctId': 'NCT02308033', 'acronym': 'SMART GIVES', 'briefTitle': 'Multi-Center Study of New Medications to Treat Vaginal Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Curatek Pharmaceuticals, LLC'}, 'officialTitle': 'Solubilized Metronidazole And/oR Terconazole Gels Intra-Vaginal Efficacy and Safety', 'orgStudyIdInfo': {'id': 'MTC-001 (Trial 2)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metronidazole vaginal gel', 'description': 'One applicator full at bedtime', 'interventionNames': ['Drug: Metronidazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Gel vehicle', 'description': 'One applicator full at bedtime', 'interventionNames': ['Drug: Gel vehicle']}], 'interventions': [{'name': 'Metronidazole', 'type': 'DRUG', 'armGroupLabels': ['Metronidazole vaginal gel']}, {'name': 'Gel vehicle', 'type': 'DRUG', 'armGroupLabels': ['Gel vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'MomDoc Womens Health Research', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'NEA Baptist Clinic', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Gossmont Center for Clinical Research', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Genesis Center for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medical Center for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80209', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Downtown Women's Health Care", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Red Rocks Ob/Gyn', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '06606', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': "Women's Health CT Ob/Gyn", 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Segal Institute for Clinical Research', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Discovery Clinical Research', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Regents University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30075', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta North Gynecology', 'geoPoint': {'lat': 34.02316, 'lon': 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