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

• Status: Unknown status
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marjan Industria e Comercio ltda
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Metronidazole; Nystatin

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 ;

• Participation in any experimental study or ingestion of any experimental drug 12 months before the start of this study.