Placebo-Controlled Trial of Intravaginal Clindamycin 2% Cream for the Treatment of Bacterial Vaginosis

OBJECTIVE:To compare the safety and efficacy of intravaginal clindamycin 2% cream with placebo in nonpregnant women with bacterial vaginosis.DESIGN:A randomized, double-blind, placebo-controlled clinical trial.SETTING:Ambulatory patients in the general community.PATIENTS:Two hundred fifteen nonpregnant outpatients with a diagnosis of bacterial vaginosis were entered into this study. Of the 134 evaluable patients, 65 received clindamycin and 69 placebo. Demographic parameters were comparable between the two treatment groups.INTERVENTION:Study subjects were equally randomized to receive either 5 g of clindamycin 2% vaginal cream or placebo cream for seven nights.MAIN OUTCOME MEASURES:Clinical and microbiologic follow-up evaluations were scheduled for 5–10 days and 25–39 days posttreatment. Patients were interviewed about signs and symptoms, adverse events, and compliance. Diagnostic examinations were performed.RESULTS:Clinical success rates (cure and improvement) occurred in 50 of 65 patients who received c...