- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02186145
Efficacy and Safety Study of Metronidazole, Nystatin and Dexamethasone Combination Therapy in Bacterial and Fungal Vaginal Infections
April 8, 2015 updated by: Marjan Industria e Comercio ltda
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
160
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
Santo André, SP, Brazil, 09190-615
- Faculty of Medicine of ABC (FMABC)
-
Contact:
- Marcus Vinícius Seroqui, Site Clinical Trials Manager
- Phone Number: +55 11 2829-5148
- Email: mv_seroqui@yahoo.com.br
-
Principal Investigator:
- Emerson Oliveira, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
|
Active Comparator: Flagyl
Vaginal cream of metronidazole 500 mg, nystatin 100.000
UI - once a day.
Period: 10 days
|
Vaginal cream of metronidazole and nystatin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Therapeutic cure
Time Frame: Day 21-35
|
Therapeutic cure which is based on a combination of clinical outcome and Gram's stain results (Nugentscore)/mycological eradication.
|
Day 21-35
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation on vulvovaginal inflammation
Time Frame: 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.
|
21 - 35 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Anticipated)
January 1, 2017
Study Completion (Anticipated)
January 1, 2017
Study Registration Dates
First Submitted
July 7, 2014
First Submitted That Met QC Criteria
July 9, 2014
First Posted (Estimate)
July 10, 2014
Study Record Updates
Last Update Posted (Estimate)
April 9, 2015
Last Update Submitted That Met QC Criteria
April 8, 2015
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Vaginal Diseases
- Vaginitis
- Infections
- Communicable Diseases
- Vaginosis, Bacterial
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Anti-Bacterial Agents
- Membrane Transport Modulators
- Antifungal Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Ionophores
- Dexamethasone
- Metronidazole
- Nystatin
Other Study ID Numbers
- MJ 3002-13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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