Efficacy of clindamycin vaginal ovule (3-day treatment) vs. clindamycin vaginal cream (7-day treatment) in bacterial vaginosis.
OBJECTIVE
To compare the efficacy and safety of a 3-day regimen of clindamycin vaginal ovules with a 7-day regimen of clindamycin vaginal cream for the treatment of bacterial vaginosis (BV).


METHODS
Women with a clinical diagnosis of BV were treated with a 3-day course of clindamycin ovules or a 7-day course of clindamycin cream administered intravaginally. Three hundred and eighty-four patients received study drug and were included in the evaluable patient population (ovule group, n = 204; cream group, n = 180). Assessments included pelvic examination and diagnostic testing. Primary efficacy endpoints were a resolution of two of three diagnostic criteria at the first follow-up visit and three of three diagnostic criteria at the second.


RESULTS
Cure rates in the evaluable patient population were similar between treatment groups: 53.7% (109/204) for the ovule group and 47.8% (85/180) for the cream group (p = 0.2471, 95% CI -4.1-16.0%). The most commonly reported medical event, vulvovaginal pruritus, had similar incidence in both treatment groups.


CONCLUSIONS
A 3-day course of clindamycin vaginal ovules is as effective and well-tolerated as a 7-day course of clindamycin vaginal cream in the treatment of BV.
Sobel
J
J
Division of Infectious Diseases, Detroit Medical Center, Wayne State University School of Medicine, MI 48201, USA.
Peipert
J F
JF
McGregor
J A
JA
Livengood
C
C
Martin
M
M
Robbins
J
J
Wajszczuk
C P
CP
D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002981:Clindamycin / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D018709:Statistics, Nonparametric; D014622:Vaginal Creams, Foams, and Jellies; D016585:Vaginosis, Bacterial / Q000188:drug therapy* / Q000382:microbiology
D000900:Anti-Bacterial Agents; D014622:Vaginal Creams, Foams, and Jellies; D002981:Clindamycin