Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-01-07 @ 5:27 AM
Study NCT ID:
NCT06835361
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2025-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis
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': 'D003022', 'term': 'Clotrimazole'}, {'id': 'D007792', 'term': 'Lactulose'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Masking : Single (Evaluator-blinded)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 264}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2025-01-31', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion (%) of patients with clinical and microbiological response (recovery)', 'timeFrame': 'Day 25 (Visit 4)'}], 'secondaryOutcomes': [{'measure': 'Proportion (%) of patients with clinical response (recovery)', 'timeFrame': 'by Visits 2 (Day 8) and 3 (Day 15)'}, {'measure': 'Proportion (%) of patients with microbiological recovery', 'timeFrame': 'by Visits 2 (Day 8) and 3 (Day 15)'}, {'measure': 'Assessment of the severity of subjective and objective signs and symptoms on a 4-point scale', 'timeFrame': 'by Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25)'}, {'measure': 'Patient evaluation of therapy efficacy using a 5-point scale', 'timeFrame': 'at Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25)'}, {'measure': 'Change in Lactobacillus content as determined by molecular biological examination of vaginal secretions (real-time PCR) compared to baseline', 'timeFrame': 'by Visits 3 (Day 15) and 4 (Day 25)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clotrimazole+Lactulose', 'Candidal Vulvovaginitis', 'Vulvovaginal Candidiasis', 'Clotrimazole', 'Lactulose', 'Antifungal Therapy', 'Prebiotic', 'Vaginal Suppositories', 'Canesten', 'Microbiological Recovery', 'Women's Health', 'Vaginal Microbiota'], 'conditions': ['Candidal Vulvovaginitis (ICD-10 Code: B37.3)', 'Vulvovaginal Candidiasis (VVC)']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the efficacy and safety of the combination drug Clotrimazole+Lactulose with the monocomponent product Canesten® (clotrimazole) in adult women diagnosed with candidal vulvovaginitis. The primary objective was to confirm the superiority of the combination drug in terms of clinical and microbiological response on Day 25 of the study.', 'detailedDescription': 'The study was conducted using an adaptive design to evaluate the impact of lactulose on the course of fungal infections. The primary endpoint was the proportion of patients achieving clinical and microbiological recovery on Day 25 (Visit 4). Secondary endpoints included assessment of symptom severity, changes in Lactobacillus content, and patient satisfaction with therapy. Participants were randomized into three groups: Clotrimazole+Lactulose, Canesten, and Lactulose.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18 to 60 years.\n* Clinically and microbiologically confirmed diagnosis of candidal vulvovaginitis.\n* Negative pregnancy test at screening.\n* Agreement to use reliable contraception throughout the study and for 30 days after its completion.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Diagnosed bacterial vaginosis.\n* Chronic inflammatory or atrophic diseases of the female genital organs.\n* History of malignant neoplasms.\n* Use of systemic antibiotics or antifungal drugs within 2 weeks prior to screening.'}, 'identificationModule': {'nctId': 'NCT06835361', 'briefTitle': 'Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AVVA Pharmaceuticals Ltd.'}, 'officialTitle': 'International Open-label Randomized Comparative Clinical Study of Efficacy and Safety of Clotrimazole+Lactulose, Vaginal Suppositories (AVVA RUS JSC, Russia) Vs. a Clotrimazole Monocomponent Product in Adult Female Patients with Candidal Vaginitis/vulvovaginitis', 'orgStudyIdInfo': {'id': 'Clotrimazole+Lactulose-II/III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clotrimazole+Lactulose', 'description': 'Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)', 'interventionNames': ['Drug: Clotrimazole+Lactulose.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Canesten (Clotrimazole)', 'description': 'Vaginal tablets containing clotrimazole (100 mg)', 'interventionNames': ['Drug: Canesten (Clotrimazole)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Lactulose', 'description': 'Vaginal suppositories containing lactulose (300 mg)', 'interventionNames': ['Drug: Lactulose']}], 'interventions': [{'name': 'Clotrimazole+Lactulose.', 'type': 'DRUG', 'description': 'Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)', 'armGroupLabels': ['Clotrimazole+Lactulose']}, {'name': 'Canesten (Clotrimazole)', 'type': 'DRUG', 'description': 'Vaginal tablets containing clotrimazole (100 mg)', 'armGroupLabels': ['Canesten (Clotrimazole)']}, {'name': 'Lactulose', 'type': 'DRUG', 'description': 'Vaginal suppositories containing lactulose (300 mg)', 'armGroupLabels': ['Lactulose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '220004', 'city': 'Minsk', 'state': 'Minsk City', 'status': 'RECRUITING', 'country': 'Belarus', 'contacts': [{'name': 'Alina V Krakasevich', 'role': 'CONTACT', 'email': 'info@1crp.by'}], 'facility': 'Healthcare Institution "1st Central District Polyclinic of the Central District of Minsk"', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'city': 'Minsk', 'status': 'RECRUITING', 'country': 'Belarus', 'contacts': [{'name': 'Elena V Golovko', 'role': 'CONTACT', 'email': 'info@14crp.by', 'phone': '+375 17 200 18 96'}], 'facility': 'Healthcare Institution "14th Central District Polyclinic of the Partizansky District of Minsk"', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'city': 'Minsk', 'status': 'RECRUITING', 'country': 'Belarus', 'contacts': [{'name': 'Elena E Yarosh', 'role': 'CONTACT', 'email': 'lpu2crp@gmail.com', 'phone': '+375 17 256 56 42'}], 'facility': 'Healthcare Institution "2nd Central District Polyclinic of the Frunzensky District of Minsk"', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'city': 'Minsk', 'status': 'RECRUITING', 'country': 'Belarus', 'contacts': [{'name': 'Elena A Malyavskaya', 'role': 'CONTACT', 'email': 'info@4gp.by', 'phone': '+375 17 374-67-69'}], 'facility': 'Healthcare Institution "4th City Polyclinic" of Minsk', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'city': 'Minsk', 'status': 'RECRUITING', 'country': 'Belarus', 'contacts': [{'name': 'Veronika D Babkova', 'role': 'CONTACT', 'email': 'info@5gp.by', 'phone': '+375 17 278 10 70'}], 'facility': 'Healthcare Institution "5th City Clinical Polyclinic" of Minsk', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'city': 'Minsk', 'status': 'RECRUITING', 'country': 'Belarus', 'contacts': [{'name': 'Larisa I Ershova', 'role': 'CONTACT', 'email': 'center@makaenka17med.by', 'phone': '+375 17 358 90 92'}], 'facility': 'State Institution "Republican Center of Medical Rehabilitation and Balneotherapy"', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'city': 'Ryazan', 'state': 'Ryazan Oblast', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Dmitry Sonin', 'role': 'CONTACT', 'email': 'okkvd@ryazan.gov.ru', 'phone': '+7 (4912) 27-50-82'}], 'facility': 'SBI RR "Regional Clinical Skin and Venereal Dispensary"', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}], 'centralContacts': [{'name': 'Sergey Tolmachev', 'role': 'CONTACT', 'email': 'tolmachev@rnd.avvapharma.com', 'phone': '+7 495 2690016'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AVVA Pharmaceuticals Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}