Conditions: Vulvovaginal Candidiasis
Keywords: VVC candidiasis vaginal candidiasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 229
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: placebo pessary, single dose arm 2: Arasertaconazole nitrate 150 mg pessary, single dose arm 3: Arasertaconazole nitrate 300 mg pessary, single dose arm 4: Arasertaconazole nitrate 600 mg pessary, single dose

Interventions: intervention 1: arasertaconazole nitrate intervention 2: placebo
Intervention descriptions: intervention 1: Arasertaconazole nitrate pessary, placebo pessary intervention 2: placebo, single dose

Protocol document: