Efficacy, Safety LactiSal 1% Gel, LactSal 50 mg, Clotrimazole 100 mg Tablet in Treatment Vulvovaginal Candidiasis

NCT02907307 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-03-08

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy and safety of LactiSal 1%vaginal gel and LactiSal 50 mg vaginal tablet with the standart treatment of clotrimazole 100 mg vaginal tablet in woman with vulvovaginal candidiasis (VVC)

Conditions

  • Vulvovaginal Candidiasis

Interventions

DEVICE

LactiSal vaginal gel 1%

to be administered daily intravaginally for 6 days

DEVICE

LactiSal vaginal tablet 50mg

to be administered daily intravaginally for 6 days

DRUG

Clotrimazole vaginal tablet 100mg

to be administered daily intravaginally for 6 days

Sponsors & Collaborators

  • Medinova AG

    lead INDUSTRY

Principal Investigators

  • Michael Halaška, MD · Nemocnice Bulovka, 1. LF UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-31
Primary Completion
2019-12-31
Completion
2020-07-31

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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 NCT02907307 on ClinicalTrials.gov