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CLINDAMYCIN Phosphate Vaginal Cream (GREENSTONE LLC) Clinical Studies

CLINICAL STUDIES

In two clinical studies involving 674 evaluable non-pregnant women with bacterial vaginosis comparing Clindamycin phosphate vaginal cream 2% for 3 or 7 days, the clinical cure rates, determined at 1 month posttherapy, ranged from 72% to 81% for the 3-day treatment and 84% to 86% for the 7-day treatment.

Clindamycin Phosphate Vaginal Cream 2% 3 DayClindamycin Phosphate Vaginal Cream 2% 7 Day
US Study94/13172%110/12886%
European Study161/19981%181/21684%

In a clinical study involving 249 evaluable pregnant patients in the second and third trimester treated for 7 days, the clinical cure rate, determined at 1 month posttherapy, was 60% (77/129) in the clindamycin arm and 9% (11/120) for the vehicle arm. The determination of clinical cure was based on the absence of a "fishy" amine odor when the vaginal discharge was mixed with a 10% KOH solution and the absence of clue cells on microscopic examination.

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