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Efficacy Vulvovaginitis Candida

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00199264
Recruitment Status : Terminated
First Posted : September 20, 2005
Last Update Posted : October 3, 2006
Information provided by:
J. Uriach and Company

Brief Summary:
To compare the therapeutic efficacy of 10 mg, 40 mg, 80 mg, 160 mg and 320 mg of albaconazole, as a single oral dose, in women affected by acute non-complicated vulvovaginitis due to Candida spp.

Condition or disease Intervention/treatment Phase
Candidiasis Vulvaginitis Drug: Albaconazole oral solution Phase 2

Detailed Description:
Multi-center, open-label, randomized study, controlled with fluconazole.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Blind, Randomized, Dose-Finding Study Versus Fluconazole to Assess the Efficacy and Tolerability of Five Single Doses of Albaconazole in the Treatment of Acute Non-Recurrent Candida Spp Vulvovaginitis
Study Start Date : June 2004
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Primary Efficacy VariableThe primary efficacy assessment will be carried out 24 ± 4 (FV) days following treatment or at the last patient's.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ambulatory patients over 18 years of age, with a vaginal score sum ³ 2 and KOH fresh examination positive for yeasts (hyphae, pseudohyphae). The diagnosis must be later confirmed with a positive Candida spp. culture.

Exclusion Criteria:

  • Patients with recurrent disease, prior treatment with antifungal agents within the last 7 days, immunosuppression, pregnant or lactating women, other vulvovaginal diseases, other systemic diseases, hypersensitivity to azole derivatives.Number of patients: 78 patients included to obtain 60 evaluable patients

Information from the National Library of Medicine

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 identifier (NCT number): NCT00199264

Sponsors and Collaborators
J. Uriach and Company
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Study Chair: Ricardo Negroni, Dr Hosp Infecciosas F J Muñiz, Buenos Aires. Argentina
Layout table for additonal information Identifier: NCT00199264    
Other Study ID Numbers: ICO8ATM/2/03
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 3, 2006
Last Verified: October 2003
Keywords provided by J. Uriach and Company:
antifungal oral therapy
efficacy acute candidiasis vulvaginitis
Additional relevant MeSH terms:
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Vaginal Diseases
Vulvar Diseases
Antifungal Agents
Anti-Infective Agents