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

NCT02186145 | Unknown Phase 3 DMC

• 1 other identifier: MJ 3002-13
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Vaginosis; Fungal Vaginal Infections

Outcome Measures

Primary Outcomes (1)

• Therapeutic cure

  Therapeutic cure which is based on a combination of clinical outcome and Gram's stain results (Nugentscore)/mycological eradication.

  Day 21-35

Secondary Outcomes (1)

• Evaluation on vulvovaginal inflammation

  21 - 35 days

Study Arms (2)

Association of metronidazole; nystatin and dexamethasone

EXPERIMENTAL

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

Flagyl

ACTIVE COMPARATOR

Vaginal cream of metronidazole 500 mg, nystatin 100.000 UI - once a day. Period: 10 days

Drug: Flagyl

Interventions

Association of metronidazole; nystatin and dexamethasone DRUG

Association of metronidazole; nystatin and dexamethasone

Flagyl DRUG

Vaginal cream of metronidazole and nystatin

Also known as: Flagyl-Nistatina (Sanofi Aventis)

Flagyl

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Marjan Industria e Comercio ltda: lead

Study Sites (1)

Faculty of Medicine of ABC (FMABC)

Santo André, São Paulo, 09190-615, Brazil

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Nystatin; Dexamethasone; Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 10, 2014
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 9, 2015

Record last verified: 2014-07

Locations

BR (1)