Efficacy Vulvovaginitis Candida

Uriach

Status and phase: Terminated; Phase 2

Conditions: Candidiasis Vulvaginitis

Treatments: Drug: Albaconazole oral solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00199264

ICO8ATM/2/03

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)