NCT06411314

Efficacy and Safety of Natamycin and Lactulose Vaginal Suppositories in Treatment of Vulvovaginal Candidiasis

Name: Clinical Trial NCT06411314
Creator: Avva Rus, JSC
Keywords: Vulvovaginal Candidiasis, Genital, Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories, Phase 3, combination product, clinical trial, Russian Federation

Efficacy and Safety of Vaginal Suppositories Containing Combination of Natamycin and Lactulose in Treatment of Vulvovaginal Candidiasis: International, Randomized, Controlled, Superiority Clinical Trial

Avva Rus, JSC·Phase 3·ClinicalTrials.gov·combination productCompleted

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Vulvovaginal Candidiasis, Genital
Drug/Device/Intervention: Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories
Study type: Interventional
Intervention type: combination product

Sponsor & location

Primary sponsor: Avva Rus, JSC
Location: Moscow, Russian Federation

Timeline & enrollment

Phase: Phase 3
Start date: Dec 29, 2022
End date: Sep 22, 2023
Enrollment: 218 participants

Primary outcome

Proportion (%) of patients who achieved a clinical response (recovery) at Visit 2

Summary

The purpose is to study superior efficacy of combination of Natamycin and Lactulose (Natamycin 100 mg + Lactulose 300 mg vaginal suppositories) compared to Pimafucin (Natamycin 100 mg vaginal suppositories), or Lactulose 300 mg vaginal suppositories. The second objective of the study was to investigate the safety of the combination suppositories in the treatment of vulvovaginal candidiasis in non-pregnant adult females.

ICD-10 classifications

Candidiasis of vulva and vaginaCandidiasis, unspecifiedCandidiasisCandidiasis of other urogenital sitesAbscess of vulva

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06411314
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06411314 through Pure Global AI's free database. This Phase 3 trial is sponsored by Avva Rus, JSC and is currently Completed. The study focuses on Vulvovaginal Candidiasis, Genital. Target enrollment is 218 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.