search
Back to results

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

Primary Purpose

Bacterial Vaginosis, Fungal Vaginal Infections

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Association of metronidazole; nystatin and dexamethasone
Flagyl
Sponsored by
Marjan Industria e Comercio ltda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginosis

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine of ABC (FMABC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Association of metronidazole; nystatin and dexamethasone

Flagyl

Arm Description

Intravaginal cream containing metronidazole (500 mg), nystatin ( 100.000 UI) and dexamethasone (0,32 mg) once a day. Period: 10 days.

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

Outcomes

Primary Outcome Measures

Therapeutic cure
Therapeutic cure which is based on a combination of clinical outcome and Gram's stain results (Nugentscore)/mycological eradication.

Secondary Outcome Measures

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.

Full Information

First Posted
July 7, 2014
Last Updated
April 8, 2015
Sponsor
Marjan Industria e Comercio ltda
search

1. Study Identification

Unique Protocol Identification Number
NCT02186145
Brief Title
Efficacy and Safety Study of Metronidazole, Nystatin and Dexamethasone Combination Therapy in 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 Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marjan Industria e Comercio ltda

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis, Fungal Vaginal Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Association of metronidazole; nystatin and dexamethasone
Arm Type
Experimental
Arm Description
Intravaginal cream containing metronidazole (500 mg), nystatin ( 100.000 UI) and dexamethasone (0,32 mg) once a day. Period: 10 days.
Arm Title
Flagyl
Arm Type
Active Comparator
Arm Description
Vaginal cream of metronidazole 500 mg, nystatin 100.000 UI - once a day. Period: 10 days
Intervention Type
Drug
Intervention Name(s)
Association of metronidazole; nystatin and dexamethasone
Intervention Type
Drug
Intervention Name(s)
Flagyl
Other Intervention Name(s)
Flagyl-Nistatina (Sanofi Aventis)
Intervention Description
Vaginal cream of metronidazole and nystatin
Primary Outcome Measure Information:
Title
Therapeutic cure
Description
Therapeutic cure which is based on a combination of clinical outcome and Gram's stain results (Nugentscore)/mycological eradication.
Time Frame
Day 21-35
Secondary Outcome Measure Information:
Title
Evaluation on vulvovaginal inflammation
Description
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.
Time Frame
21 - 35 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Faculty of Medicine of ABC (FMABC)
City
Santo André
State/Province
SP
ZIP/Postal Code
09190-615
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcus Vinícius Seroqui, Site Clinical Trials Manager
Phone
+55 11 2829-5148
Email
mv_seroqui@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Emerson Oliveira, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs