Efficacy Vulvovaginitis Candida

This study has been terminated.

First Received: September 13, 2005 Last Updated: October 2, 2006 History of Changes

Sponsored by:	J. Uriach and Company
Information provided by:	J. Uriach and Company
ClinicalTrials.gov Identifier:	NCT00199264

Purpose

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	Intervention	Phase
Candidiasis Vulvaginitis	Drug: Albaconazole oral solution	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Yeast Infections

Drug Information available for: Albaconazole

U.S. FDA Resources

Further study details as provided by J. Uriach and Company:

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.

Estimated Enrollment:	60
Study Start Date:	June 2004
Estimated Study Completion Date:	October 2004

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199264

Sponsors and Collaborators

J. Uriach and Company

Investigators

Study Chair:

Ricardo Negroni, Dr

Hosp Infecciosas F J Muñiz, Buenos Aires. Argentina

More Information

No publications provided

Study ID Numbers:	ICO8ATM/2/03
Study First Received:	September 13, 2005
Last Updated:	October 2, 2006
ClinicalTrials.gov Identifier:	NCT00199264 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by J. Uriach and Company:

antifungal oral therapy
efficacy acute candidiasis vulvaginitis

Study placed in the following topic categories:

Fluconazole
Genital Diseases, Female
Mycoses
Signs and Symptoms
Vulvovaginitis
Candidiasis, Vulvovaginal

Candidiasis
Antifungal Agents
Vaginitis
Vaginal Diseases
Torulopsis
Vulvar Diseases

Additional relevant MeSH terms:

Genital Diseases, Female
Mycoses
Vulvovaginitis
Candidiasis

Vaginitis
Vaginal Diseases
Vulvitis
Vulvar Diseases

ClinicalTrials.gov processed this record on July 02, 2009