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Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis

NCT00889356 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2009-04-28

No results posted yet for this study

Summary

The purpose of this study is to determine the Efficacy, Tolerability \& Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, used for 7 consecutive days in patients with Mixed-Type Vaginosis compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream.

Conditions

  • Candidiasis
  • Bacterial Vaginosis

Interventions

DRUG

Clindamycin 100mg and Ketoconazole 400mg

1 vaginal capsule once a day at night

DRUG

Tetracycline 100mg and Amphotericin B 50mg

One full applicator, once a day at night

Sponsors & Collaborators

  • Zodiac Produtos Farmaceuticos S.A.

    lead INDUSTRY

Principal Investigators

  • Rogerio Bonassi Machado, MD · CRM Regional Council of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Brazil

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 NCT00889356 on ClinicalTrials.gov