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

Condition(s) targeted: Bacterial Vaginosis; Fungal Vaginal Infections

Intervention: Association of metronidazole; nystatin and dexamethasone (Drug); Flagyl (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Marjan Industria e Comercio ltda

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: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Therapeutic cure

Secondary outcome: Evaluation on vulvovaginal inflammation

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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.

Faculty of Medicine of ABC (FMABC), Santo André, SP 09190-615, Brazil; Not yet recruiting
Marcus Vinícius Seroqui, Site Clinical Trials Manager, Phone: +55 11 2829-5148, Email: mv_seroqui@yahoo.com.br
Emerson Oliveira, MD, Principal Investigator

Starting date: January 2016
Last updated: April 8, 2015