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

Bacterial Vaginosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02186145
• Other study ID #: MJ 3002-13
• Status: Not yet recruiting
• Phase: Phase 3
• First received: July 7, 2014
• Last updated: April 8, 2015
• Start date: January 2016
• Est. completion date: January 2017

Study information

• Verified date: July 2014
• Source: Marjan Industria e Comercio ltda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Fungal Vaginal Infections
• Infection
• Vaginosis, Bacterial

Intervention

Drug:
• Association of metronidazole; nystatin and dexamethasone

• Flagyl
Vaginal cream of metronidazole and nystatin

Locations

Country	Name	City	State
Brazil	Faculty of Medicine of ABC (FMABC)	Santo André	SP

Sponsors (1)

Lead Sponsor	Collaborator
Marjan Industria e Comercio ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic cure	Therapeutic cure which is based on a combination of clinical outcome and Gram's stain results (Nugentscore)/mycological eradication.	Day 21-35	No
Secondary	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	No