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Efficacy and Safety of the Association of Clotrimazole and Metronidazole in the Treatment of Vaginal Discharge From Different Etiologies.

NCT02713139 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-03-18

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety of the association clotrimazole 200mg and metronidazole 0,75%(Clopistatin 5DT®) and whether it is superior when compared with metronidazole 100mg/g (gynecologic Flagyl®) and clotrimazole 20mg/g (Gino-Canesten® 3) in the syndromic treatment of vaginal discharge from different etiologies.

Conditions

  • Sexual Active Women
  • Vaginal Discharge

Interventions

DRUG

Clotrimazole + Metronidazole

Vaginal cream with Clotrimazole 200mg and Metronidazole 0,75%. Apply once per day, before bedtime, for 5 (five) days.

DRUG

Metronidazole

Vaginal gel with Metronifdazole 100mg/g. Apply once per day, before bedtime, for 10(ten) days.

DRUG

Clotrimazole

Vaginal cream with Clotrimazole 20mg/g. Apply once per day, before bedtime, for 3 (three) days.

Sponsors & Collaborators

  • Ache Laboratorios Farmaceuticos S.A.

    lead INDUSTRY

Principal Investigators

  • Eduardo A. Junior, MD · Scentryphar Pesquisa Clínica Ltda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-03-31

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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 NCT02713139 on ClinicalTrials.gov