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

NCT ID: NCT02186145

Last Updated: 2015-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-01-31

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.

Conditions

Bacterial Vaginosis; Fungal Vaginal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Association of metronidazole; nystatin and dexamethasone

Intervention Type: DRUG

Flagyl

Vaginal cream of metronidazole 500 mg, nystatin 100.000 UI - once a day. Period: 10 days

Group Type: ACTIVE_COMPARATOR

Flagyl

Intervention Type: DRUG

Vaginal cream of metronidazole and nystatin

Interventions

Association of metronidazole; nystatin and dexamethasone

Intervention Type: DRUG

Flagyl

Vaginal cream of metronidazole and nystatin

Intervention Type: DRUG

Other Intervention Names

Flagyl-Nistatina (Sanofi Aventis)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Marjan Industria e Comercio ltda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Faculty of Medicine of ABC (FMABC)

Santo André, São Paulo, Brazil

Countries

Brazil

Facility Contacts

Marcus Vinícius Seroqui, Site Clinical Trials Manager

Role: primary

mv_seroqui@yahoo.com.br

+55 11 2829-5148

Other Identifiers

MJ 3002-13

Identifier Type: -

Identifier Source: org_study_id