Conditions: Vulvovaginal Candidiasis
Keywords: Vulvovaginal Candidiasis Terconazole
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 572
Healthy volunteers: no

Brief summary:
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories, 80 mg(Reference Product) in the treatment of subjects with vulvovaginal candidiasis in order to establish bioequivalence.

Detailed description:

Arms:
arm 1: Terconazole Vaginal Suppository arm 2: Terazol Vaginal Suppository

Interventions: intervention 1: Terconazole Vaginal Suppository intervention 2: Terazol Vaginal Suppository
Intervention descriptions: intervention 1: Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days intervention 2: Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days

Protocol document: