MedTrace Logo

An Efficacy and Safety Study of Miconazole and Hydrocortisone Cream in the Treatment of Vulvar Candidiasis

NCT01769339 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2013-03-25

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the efficacy and safety of miconazole plus hydrocortisone cream in the treatment of participants with vulvar candidiasis (yeast infection of the vulva).

Conditions

  • Vulva; Candidiasis

Interventions

DRUG

Miconazole plus Hydrocortisone

Participants will apply miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14 by rubbing gently until it has been completely penetrated into the affected vulvar (the tissues around the opening to the vagina) area and the treatment should be continued without interruption. Participants will be assessed for signs and symptoms of vulvar candidiasis at Day 14. Medication will be continued till Day 28, if signs and symptoms of vulvar candidiasis are not cured clinically on Day 14.

Sponsors & Collaborators

  • Janssen Pharmaceutica

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutica Clinical Trial · Janssen Pharmaceutica

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-06-30
Completion
2009-06-30

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 NCT01769339 on ClinicalTrials.gov