Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis
NCT ID: NCT06835361
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
264 participants
INTERVENTIONAL
2024-02-29
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Clotrimazole+Lactulose
Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)
Clotrimazole+Lactulose.
Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)
Canesten (Clotrimazole)
Vaginal tablets containing clotrimazole (100 mg)
Canesten (Clotrimazole)
Vaginal tablets containing clotrimazole (100 mg)
Lactulose
Vaginal suppositories containing lactulose (300 mg)
Lactulose
Vaginal suppositories containing lactulose (300 mg)
Interventions
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Clotrimazole+Lactulose.
Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)
Canesten (Clotrimazole)
Vaginal tablets containing clotrimazole (100 mg)
Lactulose
Vaginal suppositories containing lactulose (300 mg)
Eligibility Criteria
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Inclusion Criteria
* Clinically and microbiologically confirmed diagnosis of candidal vulvovaginitis.
* Negative pregnancy test at screening.
* Agreement to use reliable contraception throughout the study and for 30 days after its completion.
* Signed informed consent.
Exclusion Criteria
* Diagnosed bacterial vaginosis.
* Chronic inflammatory or atrophic diseases of the female genital organs.
* History of malignant neoplasms.
* Use of systemic antibiotics or antifungal drugs within 2 weeks prior to screening.
18 Years
60 Years
FEMALE
No
Sponsors
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AVVA Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Locations
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Healthcare Institution "1st Central District Polyclinic of the Central District of Minsk"
Minsk, Minsk City, Belarus
Healthcare Institution "14th Central District Polyclinic of the Partizansky District of Minsk"
Minsk, , Belarus
Healthcare Institution "2nd Central District Polyclinic of the Frunzensky District of Minsk"
Minsk, , Belarus
Healthcare Institution "4th City Polyclinic" of Minsk
Minsk, , Belarus
Healthcare Institution "5th City Clinical Polyclinic" of Minsk
Minsk, , Belarus
State Institution "Republican Center of Medical Rehabilitation and Balneotherapy"
Minsk, , Belarus
SBI RR "Regional Clinical Skin and Venereal Dispensary"
Ryazan, Ryazan Oblast, Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Clotrimazole+Lactulose-II/III
Identifier Type: -
Identifier Source: org_study_id
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