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

Phase 3

• Conditions: Bacterial Vaginosis; Fungal Vaginal Infections
• Interventions: Drug: Association of metronidazole; nystatin and dexamethasone; Drug: Flagyl

• Registration Number: NCT02186145
• Lead Sponsor: Marjan Industria e Comercio ltda

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-07
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-09
• Study First Posted: 2014-07-10
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-09
• Study Start: 2016-01
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Association of metronidazole; nystatin and dexamethasone	Association of metronidazole; nystatin and dexamethasone	Intravaginal cream containing metronidazole (500 mg), nystatin ( 100.000 UI) and dexamethasone (0,32 mg) once a day. Period: 10 days.
Flagyl	Flagyl	Vaginal cream of metronidazole 500 mg, nystatin 100.000 UI - once a day. Period: 10 days

Primary Outcome Measures

Name	Time	Method
Therapeutic cure	Day 21-35	Therapeutic cure which is based on a combination of clinical outcome and Gram's stain results (Nugentscore)/mycological eradication.

Secondary Outcome Measures

Name	Time	Method
Evaluation on vulvovaginal inflammation	21 - 35 days	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.

Trial Locations

Locations (1)

Faculty of Medicine of ABC (FMABC); 🇧🇷 Santo André, SP, Brazil