MedTrace Logo

Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis

NCT06835361 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2025-02-19

No results posted yet for this study

Summary

This study aims to compare the efficacy and safety of the combination drug Clotrimazole+Lactulose with the monocomponent product Canesten® (clotrimazole) in adult women diagnosed with candidal vulvovaginitis. The primary objective was to confirm the superiority of the combination drug in terms of clinical and microbiological response on Day 25 of the study.

Conditions

  • Candidal Vulvovaginitis (ICD-10 Code: B37.3)
  • Vulvovaginal Candidiasis (VVC)

Interventions

DRUG

Clotrimazole+Lactulose.

Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)

DRUG

Canesten (Clotrimazole)

Vaginal tablets containing clotrimazole (100 mg)

DRUG

Lactulose

Vaginal suppositories containing lactulose (300 mg)

Sponsors & Collaborators

  • AVVA Pharmaceuticals Ltd.

    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
2024-02-29
Primary Completion
2025-09-30
Completion
2025-11-30

Countries

  • Belarus
  • Russia

Study Locations

More Related Trials

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 NCT06835361 on ClinicalTrials.gov