Efficacy Vulvovaginitis Candida

• Status: Terminated
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: J. Uriach and Company
• Treatments: Albaconazole

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