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

Marjan Industria e Comercio ltda1 site in 1 country160 target enrollmentJanuary 2016

ConditionsBacterial Vaginosis Fungal Vaginal Infections

InterventionsAssociation of metronidazole; nystatin and dexamethasone Flagyl

DrugsAssociation of metronidazole; nystatin and dexamethasone Flagyl

Overview

Phase: Phase 3
Intervention: Association of metronidazole; nystatin and dexamethasone
Conditions: Bacterial Vaginosis
Sponsor: Marjan Industria e Comercio ltda
Enrollment: 160
Locations: 1
Primary Endpoint: Therapeutic cure
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

January 2017

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Marjan Industria e Comercio ltda

Responsible Party

Sponsor

Eligibility Criteria

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 ;