Status:
TERMINATED
Efficacy Vulvovaginitis Candida
Lead Sponsor:
J. Uriach and Company
Conditions:
Candidiasis Vulvaginitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Detailed Description
Multi-center, open-label, randomized study, controlled with fluconazole.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2004
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00199264
Start Date
June 1 2004
End Date
October 1 2004
Last Update
October 3 2006
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