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

Multi-center, Randomized, Placebo-controlled, Parallel-group, Double-blinded Study to Compare the Therapeutic Efficacy, Safety, and Tolerability of 3 Single Vaginal Doses of Arasertaconazole Nitrate Pessaries in the Treatment of VVC

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).

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.