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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bacterial Vaginosis, Fungal Vaginal Infections

Intervention / Treatment
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* Drug: Association of metronidazole; nystatin and dexamethasone
* Drug: Flagyl


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Association of metronidazole; nystatin and dexamethasone<br>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<br> <br> |
| Active Comparator: Flagyl<br>Vaginal cream of metronidazole 500 mg, nystatin 100.000 UI - once a day. Period: 10 days | Drug: Flagyl<br>* Vaginal cream of metronidazole and nystatin<br>* Other names: Flagyl-Nistatina (Sanofi Aventis);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation on vulvovaginal inflammation | 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. | 21 - 35 days |