Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2026-02-28 @ 10:51 PM
Study NCT ID:
NCT02180100
Status:
COMPLETED
Last Update Posted:
2020-10-23
First Post:
2014-06-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}], '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': 'fanshangrong@163.com', 'phone': '86755-83923333', 'title': 'Prof. Shangrong Fan', 'phoneExt': '5502', 'organization': 'Peking University Shenzhen Hospital'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 35 after treatment', 'description': 'Vulvovaginal pruritus, burning and irritation', 'eventGroups': [{'id': 'EG000', 'title': 'Terconazole Vaginal Suppository', 'description': 'Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days\n\nTerconazole Vaginal Suppository: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 0, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fluconazole', 'description': 'Orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.\n\nFluconazole: orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 0, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mycological Cure 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Terconazole Vaginal Suppository', 'description': 'Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days\n\nTerconazole Vaginal Suppository: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days'}, {'id': 'OG001', 'title': 'Fluconazole', 'description': 'Orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.\n\nFluconazole: orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Between day 7-14 after treatment, an average of 10 days', 'description': 'Based on candida culture', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mycological Cure 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Terconazole Vaginal Suppository', 'description': 'Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days\n\nTerconazole Vaginal Suppository: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days'}, {'id': 'OG001', 'title': 'Fluconazole', 'description': 'Orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.\n\nFluconazole: orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Between day 28-35 after treatment, an average of 30 days', 'description': 'Based on Candida culture', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Terconazole Vaginal Suppository', 'description': 'Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days\n\nTerconazole Vaginal Suppository: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days'}, {'id': 'FG001', 'title': 'Fluconazole', 'description': 'Orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.\n\nFluconazole: orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'At Clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Terconazole Vaginal Suppository', 'description': 'Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days\n\nTerconazole Vaginal Suppository: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days'}, {'id': 'BG001', 'title': 'Fluconazole', 'description': 'Orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.\n\nFluconazole: orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-22', 'studyFirstSubmitDate': '2014-06-30', 'resultsFirstSubmitDate': '2019-08-20', 'studyFirstSubmitQcDate': '2014-07-01', 'lastUpdatePostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-22', 'studyFirstPostDateStruct': {'date': '2014-07-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mycological Cure 1', 'timeFrame': 'Between day 7-14 after treatment, an average of 10 days', 'description': 'Based on candida culture'}], 'secondaryOutcomes': [{'measure': 'Mycological Cure 2', 'timeFrame': 'Between day 28-35 after treatment, an average of 30 days', 'description': 'Based on Candida culture'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vulvovaginal Candidiasis']}, 'referencesModule': {'references': [{'pmid': '25877666', 'type': 'RESULT', 'citation': 'Li T, Zhu Y, Fan S, Liu X, Xu H, Liang Y. A randomized clinical trial of the efficacy and safety of terconazole vaginal suppository versus oral fluconazole for treating severe vulvovaginal candidiasis. Med Mycol. 2015 Jun;53(5):455-61. doi: 10.1093/mmy/myv017. Epub 2015 Apr 15.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/25877666', 'label': 'Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.', 'detailedDescription': 'This study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppository 80 mg inserted intravaginally once daily before bedtime for 6 consecutive days and oral fluconazole 150mg at day 1 and day 4 in the treatment of subjects with severe vulvovaginal candidiasis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7\n* Subject completes the informed consent process\n* Subject agrees to take study medication when scheduled\n* Subject complies with all clinical trial instructions. Commits to all follow-up visits\n* Subject agrees to abstain from sexual intercourse from the time of randomization through the first seven days immediately following treatment\n\nExclusion Criteria:\n\n* had any other sexually transmitted disease or gynaecological abnormality requiring treatment\n* had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods\n* had used antifungal medication in the week before entry; or\n* were expected to menstruate within seven days of the start of treatment\n* infected more than one candida species'}, 'identificationModule': {'nctId': 'NCT02180100', 'briefTitle': 'Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Shenzhen Hospital'}, 'officialTitle': 'A Randomized, Parallel-group Study of Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe', 'orgStudyIdInfo': {'id': 'PKUSH-GNY-2013-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Terconazole Vaginal Suppository', 'description': 'Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days', 'interventionNames': ['Drug: Terconazole Vaginal Suppository']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluconazole', 'description': 'orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.', 'interventionNames': ['Drug: Fluconazole']}], 'interventions': [{'name': 'Terconazole Vaginal Suppository', 'type': 'DRUG', 'otherNames': ['Tekangzuo Yindao Shuan'], 'description': 'Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days', 'armGroupLabels': ['Terconazole Vaginal Suppository']}, {'name': 'Fluconazole', 'type': 'DRUG', 'otherNames': ['Diflucan'], 'description': 'orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.', 'armGroupLabels': ['Fluconazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518036', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': 'Peking University Shenzhen Hosptal', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'overallOfficials': [{'name': 'Shangrong Fan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Shenzhen Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Shenzhen Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Shyndec Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof of Obstetrics and Gynecology', 'investigatorFullName': 'Shangrong Fan', 'investigatorAffiliation': 'Peking University Shenzhen Hospital'}}}}