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FLAGYL® (ER FORMULATION) (metronidazole) Clinical Studies

CLINICAL STUDIES

Bacterial vaginosis (BV) is a clinical syndrome that results from a replacement of the normal, Lactobacillus-dominant flora with several other organisms including Gardnerella vaginalis, Mobiluncus spp, Mycoplasma hominis and anaerobes (Peptostreptococcus spp and Bacteroides spp).

FLAGYL ER was studied in patients with BV in two randomized, multicenter, well-controlled, investigator blind clinical trials.3,4 A total of 557 otherwise healthy nonpregnant patients with BV were randomized to treatment with FLAGYL ER once a day for 7 days (n=270) or 2% clindamycin vaginal cream one applicator full (5 grams) once a day for 7 days (n=287).

The primary efficacy endpoint for each treatment regimen was defined as clinical cure assessed at 28–32 days post-therapy. Clinical cure was defined as a return to normal of the vaginal pH (≤4.5), absence of a "fishy" amine odor, and absence of clue cells.

The study results are presented in the table below:

Clinical Cure Rates at One Month
FLAGYL ER
% (n/N)
2% clindamycin cream
% (n/N)
*
p<0.05 versus clindamycin cream
Study 1 61% (77/126) 59% (80/135)
Study 2 62% (74/119)* 43% (50/117)

At one month post-therapy the pH of the vagina returned to normal earlier and in a greater percentage of patients in the FLAGYL ER treatment group when compared to the 2% clindamycin vaginal cream group; 72% vs. 65%, respectively. Likewise, FLAGYL ER restored the normal Lactobacillus-predominant vaginal flora in a larger percentage of patients at one month post-therapy when compared to the 2% clindamycin treated group; 74% vs. 63%, respectively.

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