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Comparative Efficacy Study of 10 mg Dequalinium Chloride (Fluomizin) in the Treatment of Vulvovaginal Candidiasis

NCT02242695 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-09-15

No results posted yet for this study

Summary

A clinical study to compare the clinical efficacy of vaginal tablets containing 10mg dequalinium chloride (Fluomizin) with the clinical efficacy of 100mg clotrimazole in patients suffering from vulvovaginal candidiasis, to assess safety of the two medications during the treatment, and to evaluate women's satisfaction with the two treatments.

Conditions

  • Vulvovaginal Candidiasis

Interventions

DRUG

Fluomizin vaginal tablets

One vaginal tablet for 6 days and 1 placebo tablet on day 7

DRUG

Canesten vaginal tablets

one vaginal tablet for 7 days

Sponsors & Collaborators

  • Mahidol University

    collaborator OTHER

  • Medinova AG

    lead INDUSTRY

Principal Investigators

  • Manopchai Thamkhantho, Prof MD · Siriraj Gynaecologic ID and Female STD Unit, Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-12-31
Completion
2016-04-30

Countries

  • Thailand

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 NCT02242695 on ClinicalTrials.gov