(clindamycin)
In two clinical studies involving 674 evaluable non-pregnant women with bacterial vaginosis comparing CLEOCIN 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.
| CLEOCIN 3 Day | CLEOCIN 7 Day | |||
|---|---|---|---|---|
US Study | 94/131 | 72% | 110/128 | 86% |
European Study | 161/199 | 81% | 181/216 | 84% |
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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