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

Marjan

Status and phase

Unknown

Phase 3

Conditions

Bacterial Vaginosis

Fungal Vaginal Infections

Treatments

Drug: Association of metronidazole; nystatin and dexamethasone

Drug: Flagyl

Study type

Interventional

Funder types

Industry

Identifiers

NCT02186145

MJ 3002-13

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.