Efficacy and Safety Study of Metronidazole, Nystatin and Dexamethasone Combination Therapy in Bacterial and Fungal Vaginal Infections
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186145
|Faculty of Medicine of ABC (FMABC)|
|Santo André, SP, Brazil, 09190-615|
|Contact: Marcus Vinícius Seroqui, Site Clinical Trials Manager +55 11 2829-5148 email@example.com|
|Principal Investigator: Emerson Oliveira, MD|