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

NCT06411314 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2024-05-13

No results posted yet for this study

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.

Conditions

  • Vulvovaginal Candidiasis, Genital

Interventions

COMBINATION_PRODUCT

Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories

1 suppository once daily at bedtime for 6 days

DRUG

Lactulose 300 mg vaginal suppositories

1 suppository once daily at bedtime for 6 days

DRUG

Pimafucin® (natamycin) 100 mg vaginal suppositories

1 suppository once daily at bedtime for 6 days

Sponsors & Collaborators

  • Avva Rus, JSC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-29
Primary Completion
2023-07-26
Completion
2023-09-22

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06411314 on ClinicalTrials.gov