Efficacy and Safety of Natamycin and Lactulose Vaginal Suppositories in Treatment of Vulvovaginal Candidiasis
NCT ID: NCT06411314
Last Updated: 2024-05-13
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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COMPLETED
PHASE3
218 participants
INTERVENTIONAL
2022-12-29
2023-09-22
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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Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories
Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories
1 suppository once daily at bedtime for 6 days
Lactulose 300 mg vaginal suppositories
Lactulose 300 mg vaginal suppositories
1 suppository once daily at bedtime for 6 days
Pimafucin® (natamycin) 100 mg vaginal suppositories
Pimafucin® (natamycin) 100 mg vaginal suppositories
1 suppository once daily at bedtime for 6 days
Interventions
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Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories
1 suppository once daily at bedtime for 6 days
Lactulose 300 mg vaginal suppositories
1 suppository once daily at bedtime for 6 days
Pimafucin® (natamycin) 100 mg vaginal suppositories
1 suppository once daily at bedtime for 6 days
Eligibility Criteria
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Inclusion Criteria
* yeast cells in the vaginal swab specimen;
* vaginal pH ≤ 4.5.
Exclusion Criteria
18 Years
60 Years
FEMALE
No
Sponsors
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Avva Rus, JSC
INDUSTRY
Responsible Party
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Locations
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Department of Reproductive Medicine and Surgery at the A.I. Evdokimov Moscow State Medical and Dental University
Moscow, , Russia
Countries
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References
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Volkova ON, Amel'chenko EV, Makeeva OV, Tolmachev SA, Lesovaya EA, Zacharia LC, Dikovskiy AV. Efficacy and safety of vaginal suppositories containing combination of Natamycin and Lactulose in treatment of vulvovaginal candidiasis: international, randomized, controlled, superiority clinical trial (combination of Natamycin and Lactulose for treatment of vulvovaginal candidiasis). BMC Womens Health. 2025 Feb 20;25(1):77. doi: 10.1186/s12905-025-03616-3.
Other Identifiers
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12/21-AVVA RUS
Identifier Type: -
Identifier Source: org_study_id
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