Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will be conducted to compare the therapeutic efficacy, safety and tolerability of three different doses of arasertaconazole nitrate (150 mg, 300 mg or 600 mg, pessaries).

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

Details

• Lead Sponsor: Ferrer Internacional S.A.

Criteria

Inclusion Criteria:

• Women aged between 18 to 65 years of age who have signed the informed consent.

• Not pregnant, not nursing.

• No indication of other vulvovaginitis or genital infections

• Positive 10% potassium hydroxide (KOH) preparation for budding yeast and/or pseudohyphae.

• Negative wet mount results for T. vaginalis and clue cells.

• Exclusion Criteria:

• Subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response.

• Hypersensitivity to imidazole products administered topically.

• Any other medical condition which in the opinion of the investigator could interfere with study conduct.