Status:
UNKNOWN
Efficacy and Safety Study of Metronidazole, Nystatin and Dexamethasone Combination Therapy in Bacterial and Fungal Vaginal Infections
Lead Sponsor:
Marjan Industria e Comercio ltda
Conditions:
Bacterial Vaginosis
Fungal Vaginal Infections
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2017
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT02186145
Start Date
January 1 2016
End Date
January 1 2017
Last Update
April 9 2015
Active Locations (1)
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1
Faculty of Medicine of ABC (FMABC)
Santo André, São Paulo, Brazil, 09190-615