Efficacy and Safety Study of Metronidazole, Nystatin and Dexamethasone Combination Therapy in Bacterial and Fungal Vaginal Infections
|ClinicalTrials.gov Identifier: NCT02186145|
Recruitment Status : Unknown
Verified July 2014 by Marjan Industria e Comercio ltda.
Recruitment status was: Not yet recruiting
First Posted : July 10, 2014
Last Update Posted : April 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Vaginosis Fungal Vaginal Infections||Drug: Association of metronidazole; nystatin and dexamethasone Drug: Flagyl||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||January 2016|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2017|
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.
Drug: Association of metronidazole; nystatin and dexamethasone
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 Name: Flagyl-Nistatina (Sanofi Aventis)
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186145
|Faculty of Medicine of ABC (FMABC)||Not yet recruiting|
|Santo André, SP, Brazil, 09190-615|
|Contact: Marcus Vinícius Seroqui, Site Clinical Trials Manager +55 11 2829-5148 firstname.lastname@example.org|
|Principal Investigator: Emerson Oliveira, MD|