NCT00199264

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

October 3, 2006

Status Verified

October 1, 2003

First QC Date

September 13, 2005

Last Update Submit

October 2, 2006

Conditions

Candidiasis Vulvaginitis

Keywords

antifungal oral therapyefficacy acute candidiasis vulvaginitis

Outcome Measures

Primary Outcomes (1)

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

Interventions

Albaconazole oral solutionDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

albaconazole

Study Officials

  • Ricardo Negroni, Dr

    Hosp Infecciosas F J Muñiz, Buenos Aires. Argentina

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

June 1, 2004

Study Completion

October 1, 2004

Last Updated

October 3, 2006

Record last verified: 2003-10