Conditions: Vulvovaginal Candidiasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 140
Healthy volunteers: no

Brief summary:
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.

Detailed description:
This study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppository 80 mg inserted intravaginally once daily before bedtime for 6 consecutive days and oral fluconazole 150mg at day 1 and day 4 in the treatment of subjects with severe vulvovaginal candidiasis.

Arms:
arm 1: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days arm 2: orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.

Interventions: intervention 1: Terconazole Vaginal Suppository intervention 2: Fluconazole
Intervention descriptions: intervention 1: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days intervention 2: orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.

Protocol document: