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Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis

NCT04813822 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-03-14

No results posted yet for this study

Summary

This study is a multicentre, three-arm, double-blind, randomized controlled, parallel-group, comparative phase II clinical trial to evaluate miconazole nitrate 2% + domiphen bromide vaginal cream in subjects with acute vulvovaginal candidiasis.

Conditions

  • Acute Vulvovaginal Candidiasis

Interventions

DRUG

Miconazole Nitrate 2% + Domiphen Bromide Low Dose

Dosage 1

DRUG

Miconazole Nitrate 2% + Domiphen Bromide High Dose

Dosage 2

DRUG

Miconazole Nitrate 2%

Active Comparator

Sponsors & Collaborators

  • Aesculape CRO Belgium BV

    lead INDUSTRY

Principal Investigators

  • Jean-Paul Deslypere, MD · Aesculape CRO Belgium BV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-09-13
Primary Completion
2022-05-31
Completion
2022-10-31

Countries

  • Belgium

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 NCT04813822 on ClinicalTrials.gov