Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-28 @ 11:47 PM
Study NCT ID:
NCT04626258
Status:
UNKNOWN
Last Update Posted:
2020-11-12
First Post:
2020-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluconazol Versus Medical Honey in the Treatment of Recurrent Vulvovaginal Candidiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 252}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-10', 'studyFirstSubmitDate': '2020-10-23', 'studyFirstSubmitQcDate': '2020-11-10', 'lastUpdatePostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaginal swab', 'timeFrame': '1 month', 'description': 'The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran®) and control (Diflucan®) groups.'}, {'measure': 'Vaginal swab', 'timeFrame': '6 months', 'description': 'The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran®) and control (Diflucan®) groups.'}, {'measure': 'Vaginal swab', 'timeFrame': '12 months', 'description': 'The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran®) and control (Diflucan®) groups.'}], 'secondaryOutcomes': [{'measure': 'Quality of life will be termined with questionnaires', 'timeFrame': '1 month', 'description': 'The secondary objectives are to investigate the effects of both treatments on the clinical cure rate and symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance therapy, and the long-term efficacy as number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, quality of life, therapy compliance, and cost of treatments for both products will be collected and compared. They will reach from no complaints-a little bit-moderate-severe'}, {'measure': 'Quality of life will be termined with questionnaires', 'timeFrame': '6 months', 'description': 'The secondary objectives are to investigate the effects of both treatments on the clinical cure rate and symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance therapy, and the long-term efficacy as number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, quality of life, therapy compliance, and cost of treatments for both products will be collected and compared.'}, {'measure': 'Quality of life will be termined with questionnaires', 'timeFrame': '9 months', 'description': 'The secondary objectives are to investigate the effects of both treatments on the clinical cure rate and symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance therapy, and the long-term efficacy as number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, quality of life, therapy compliance, and cost of treatments for both products will be collected and compared.'}, {'measure': 'Quality of life will be termined with questionnaires', 'timeFrame': '12 months', 'description': 'The secondary objectives are to investigate the effects of both treatments on the clinical cure rate and symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance therapy, and the long-term efficacy as number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, quality of life, therapy compliance, and cost of treatments for both products will be collected and compared.'}, {'measure': 'Side effect of medication will be termined with questionnaires', 'timeFrame': '1 month', 'description': 'The secondary objectives are to investigate the effects of both treatments on the clinicalcure rate and symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance therapy, and the long-term efficacy as number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, quality of life, therapy compliance, and cost of treatments for both products will be collected and compared.'}, {'measure': 'Side effect of medication will be termined with questionnaires', 'timeFrame': '6 months', 'description': 'The secondary objectives are to investigate the effects of both treatments on the clinicalcure rate and symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance therapy, and the long-term efficacy as number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, quality of life, therapy compliance, and cost of treatments for both products will be collected and compared.'}, {'measure': 'Side effect of medication will be termined with questionnaires', 'timeFrame': '9 months', 'description': 'The secondary objectives are to investigate the effects of both treatments on the clinicalcure rate and symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance therapy, and the long-term efficacy as number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, quality of life, therapy compliance, and cost of treatments for both products will be collected and compared.'}, {'measure': 'Side effect of medication will be termined with questionnaires', 'timeFrame': '12 months', 'description': 'The secondary objectives are to investigate the effects of both treatments on the clinicalcure rate and symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance therapy, and the long-term efficacy as number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, quality of life, therapy compliance, and cost of treatments for both products will be collected and compared.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Treatment', 'L-Mesitran', 'Fluconazol', 'Vaginal swabs'], 'conditions': ['Candidiasis, Vulvovaginal', 'Recurrent Candidiasis of Vagina']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of Flucanzol versus L-mesitran in the treatment of patients with recurrent vulvovaginal candidiasis. The investigator will look at vaginal swabs after 1, 6 and 12 months. The investigator included 252 patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Women of at least 18 years old\n\n * Recurrent vulvovaginal candidiasis (At least 3 episodes of clinical symptoms during the last year)\n * Clinical and microbiological diagnosis of (recurrent) vulvovaginal candidiasis at time of consultation\n * Capacity to understand, consent, and comply with the trial procedures\n\nExclusion Criteria:\n\n* Mixed vaginal infections\n\n * Pregnancy or the intention to become pregnant during the study period\n * Women using systemic or topical antifungal medication during the last 2 weeks prior to inclusion\n * Known allergies for Fluconazole or honey\n * Candida with resistance for Fluconazole'}, 'identificationModule': {'nctId': 'NCT04626258', 'briefTitle': 'Fluconazol Versus Medical Honey in the Treatment of Recurrent Vulvovaginal Candidiasis', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'A Randomized Controlled Trial to Compare the Efficacy of a Medical Grade Honey Formulation (L-Mesitran®) and Fluconazol (Diflucan®) for the Treatment of Recurrent Vulvovaginal Candidiasis', 'orgStudyIdInfo': {'id': 'NL 73794.068.20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active comparator: Fluconazol', 'description': 'Once a month one capsule Fluconazol 150 mg', 'interventionNames': ['Drug: Fluconazole']}, {'type': 'EXPERIMENTAL', 'label': 'L-Mesitran', 'description': 'The first month every day apply L-mesitran, the next five months apply L-mesitran every week on the vagina', 'interventionNames': ['Other: L-Mesitran']}], 'interventions': [{'name': 'Fluconazole', 'type': 'DRUG', 'otherNames': ['Diflucan'], 'description': 'Fluconazol once a month 150 mg capsule', 'armGroupLabels': ['Active comparator: Fluconazol']}, {'name': 'L-Mesitran', 'type': 'OTHER', 'otherNames': ['Medical honey'], 'description': 'The first month apply every day one sachet, the next five months apply every week one sachet.', 'armGroupLabels': ['L-Mesitran']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}