Back to resultsEfficacy Vulvovaginitis Candida
Primary Purpose
Candidiasis Vulvaginitis
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Albaconazole oral solution
Sponsored by
About this trial
This is an interventional treatment trial for Candidiasis Vulvaginitis focused on measuring antifungal oral therapy, efficacy acute candidiasis vulvaginitis
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Primary Efficacy VariableThe primary efficacy assessment will be carried out 24 ± 4 (FV) days following treatment or at the last patient's.
Secondary Outcome Measures
Full Information
NCT ID
NCT00199264
First Posted
September 13, 2005
Last Updated
October 2, 2006
Sponsor
J. Uriach and Company
1. Study Identification
Unique Protocol Identification Number
NCT00199264
Brief Title
Efficacy Vulvovaginitis Candida
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 Type
Interventional
2. Study Status
Record Verification Date
October 2003
Overall Recruitment Status
Terminated
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
J. Uriach and Company
4. Oversight
5. Study Description
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.
Detailed Description
Multi-center, open-label, randomized study, controlled with fluconazole.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis Vulvaginitis
Keywords
antifungal oral therapy, efficacy acute candidiasis vulvaginitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Albaconazole oral solution
Primary Outcome Measure Information:
Title
Primary Efficacy VariableThe primary efficacy assessment will be carried out 24 ± 4 (FV) days following treatment or at the last patient's.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Negroni, Dr
Organizational Affiliation
Hosp Infecciosas F J Muñiz, Buenos Aires. Argentina
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Efficacy Vulvovaginitis Candida
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