Efficacy and Safety Study of Metronidazole, Nystatin and Dexamethasone Combination Therapy in Bacterial and Fungal Vaginal Infections

April 8, 2015 updated by: Marjan Industria e Comercio ltda

Single Blind Randomized Study of Efficacy and Safety of Vaginal Cream With Association of Metronidazole, Nystatin and Dexamethasone in the Treatment of Bacterial and Fungal Vaginal Infections

The purpose of this study is to evaluate the efficacy and safety of association of metronidazole, nystatin and dexamethasone in the treatment of bacterial and fungal vaginal infections.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • SP
      • Santo André, SP, Brazil, 09190-615
        • Faculty of Medicine of ABC (FMABC)
        • Contact:
          • Marcus Vinícius Seroqui, Site Clinical Trials Manager
          • Phone Number: +55 11 2829-5148
          • Email: mv_seroqui@yahoo.com.br
        • Principal Investigator:
          • Emerson Oliveira, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Post-menarche women and premenopausal women, between 18 and 50 years old;
  • Diagnosis of bacterial vaginosis (Amsel criteria), fungal (positive KOH test)or mixed vaginal infection;
  • Patients who have regular menstrual cycles (patients with regular menstrual cycles with intervals between 21 to 35 days, duration of 1 to 7 days)

Exclusion Criteria:

  • Patients who have a known hypersensitivity to components of the formula ;
  • Pregnant and lactating women ;
  • Patients with other vaginal infections, such as infection by Trichomonas vaginalis , C. trachomatis, Neisseria gonorrhoeae , herpes or HPV.
  • Knowledge of positive test result for human immunodeficiency virus ;
  • Patients in treatment of cervical intraepithelial neoplasia or carcinoma of the cervix ;
  • Patients who have undergone gynecological procedures in the month prior to inclusion (such as cauterization of the cervix , cervical biopsy, high-frequency surgery) ;
  • Patients with other vaginal or vulvar conditions that may confound interpretation of clinical response;
  • Patients who received intravaginal or systemic antimicrobial or antifungal therapy 14 days before randomization ;
  • Patients on immunosuppressive medications (such as corticosteroids , cyclosporine , etc. ) ;
  • Known or suspected cancer ;
  • Participation in any experimental study or ingestion of any experimental drug 12 months before the start of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Association of metronidazole; nystatin and dexamethasone
Intravaginal cream containing metronidazole (500 mg), nystatin ( 100.000 UI) and dexamethasone (0,32 mg) once a day. Period: 10 days.
Active Comparator: Flagyl
Vaginal cream of metronidazole 500 mg, nystatin 100.000 UI - once a day. Period: 10 days
Vaginal cream of metronidazole and nystatin
Other Names:
  • Flagyl-Nistatina (Sanofi Aventis)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic cure
Time Frame: Day 21-35
Therapeutic cure which is based on a combination of clinical outcome and Gram's stain results (Nugentscore)/mycological eradication.
Day 21-35

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation on vulvovaginal inflammation
Time Frame: 21 - 35 days
Time resolution of symptoms; percentage of patients with Nugent score between 0-3; negative fungal culture; and subjective assessment of patients on the intensity of vulvar itching.
21 - 35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

July 7, 2014

First Submitted That Met QC Criteria

July 9, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Estimate)

April 9, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

July 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bacterial Vaginosis

Clinical Trials on Association of metronidazole; nystatin and dexamethasone

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