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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02186145
Recruitment Status : Unknown
Verified July 2014 by Marjan Industria e Comercio ltda.
Recruitment status was:  Not yet recruiting
First Posted : July 10, 2014
Last Update Posted : April 9, 2015
Information provided by (Responsible Party):
Marjan Industria e Comercio ltda

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Fungal Vaginal Infections Drug: Association of metronidazole; nystatin and dexamethasone Drug: Flagyl Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

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.
Drug: Association of metronidazole; nystatin and dexamethasone
Active Comparator: Flagyl
Vaginal cream of metronidazole 500 mg, nystatin 100.000 UI - once a day. Period: 10 days
Drug: Flagyl
Vaginal cream of metronidazole and nystatin
Other Name: Flagyl-Nistatina (Sanofi Aventis)

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02186145

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Faculty of Medicine of ABC (FMABC)
Santo André, SP, Brazil, 09190-615
Contact: Marcus Vinícius Seroqui, Site Clinical Trials Manager    +55 11 2829-5148   
Principal Investigator: Emerson Oliveira, MD         
Sponsors and Collaborators
Marjan Industria e Comercio ltda
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Responsible Party: Marjan Industria e Comercio ltda Identifier: NCT02186145    
Other Study ID Numbers: MJ 3002-13
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: July 2014
Additional relevant MeSH terms:
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Communicable Diseases
Vaginosis, Bacterial
Vaginal Diseases
Bacterial Infections
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Antifungal Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action