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Efficacy and Safety of Natamycin and Lactulose Vaginal Suppositories in Treatment of Vulvovaginal Candidiasis - Trial NCT06411314

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.

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NCT06411314
Phase 3
Completed
combination product
Trial Details
ClinicalTrials.gov โ€ข NCT06411314
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Efficacy and Safety of Natamycin and Lactulose Vaginal Suppositories in Treatment of Vulvovaginal Candidiasis
Efficacy and Safety of Vaginal Suppositories Containing Combination of Natamycin and Lactulose in Treatment of Vulvovaginal Candidiasis: International, Randomized, Controlled, Superiority Clinical Trial

Study Focus

Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories

Interventional

combination product

Sponsor & Location

Avva Rus, JSC

Moscow, Russian Federation

Timeline & Enrollment

Phase 3

Dec 29, 2022

Sep 22, 2023

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 vagina
Candidiasis, unspecified
Candidiasis
Candidiasis of other urogenital sites
Abscess of vulva

Data Source

ClinicalTrials.gov

NCT06411314

Non-Device Trial