Efficacy Vulvovaginitis Candida

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2004-10-31

Brief Summary

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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

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

Conditions

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Candidiasis Vulvaginitis

Keywords

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antifungal oral therapy efficacy acute candidiasis vulvaginitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Albaconazole oral solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Ricardo Negroni, Dr

Role: STUDY_CHAIR

Hosp Infecciosas F J Muñiz, Buenos Aires. Argentina

Other Identifiers

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ICO8ATM/2/03

Identifier Type: -

Identifier Source: org_study_id