Conditions: Candidiasis, Vulvovaginal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 240
Healthy volunteers: no

Brief summary:
The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs Fluconazole for the treatment of severe vulvovaginal candidiasis

Detailed description:
The current study is evaluating both the efficacy and safety of the 2 doses of 500 mg clotrimazole vaginal tablet administered intravaginally( at day 1 and day 4) v.s 2 doses of 150 mg fluconazole( at day 1 and day 4) for treatment of severe vulvovaginal candidiasis.The number of participants with adverse events as a measure of safety and tolerability.

Arms:
arm 1: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4) arm 2: 2 doses of 150 mg oral Fluconazole (at day1 and day4)

Interventions: intervention 1: Clotrimazole vaginal tablet intervention 2: Fluconazole
Intervention descriptions: intervention 1: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4) intervention 2: 2 doses of 150 mg oral Fluconazole (at day1 and day4)

Protocol document: