Conditions: Vulvovaginal Candidiasis
Keywords: bioequivalence butoconazole vulvovaginal candidiasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 611
Healthy volunteers: yes

Brief summary:
This was a study that compared the efficacy and safety of a generic butoconazole nitrate vaginal cream, 2% to Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2% in the treatment of vulvovaginal candidiasis caused by Candida species.

Detailed description:

Arms:
arm 1: vehicle of the test product; applied intravaginally once within 48 hours of randomization arm 2: Butoconazole Nitrate Vaginal Cream; applied intravaginally once within 48 hours of randomization arm 3: Gynazole 1 Vaginal Cream; applied intravaginally once within 48 hours of randomization

Interventions: intervention 1: Butoconazole Nitrate Vaginal Cream intervention 2: Placebo intervention 3: Gynazole 1 vaginal cream
Intervention descriptions: intervention 1: vaginal cream intervention 2: vaginal cream intervention 3: vaginal cream

Protocol document: