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.
RCT Entities:
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.
Authors: Craig R Cohen; Su-Chun Cheng; Stephen Shiboski; Tsungai Chipato; Martin Matu; James Mwangi; Monalisa E S Mutimutema; Jennifer Tuveson; Mavis Kamba; Nancy Padian; Ariane van der Straten Journal: Infect Dis Obstet Gynecol Date: 2012-10-24
Authors: Sujatha Srinivasan; Martin T Morgan; Congzhou Liu; Frederick A Matsen; Noah G Hoffman; Tina L Fiedler; Kathy J Agnew; Jeanne M Marrazzo; David N Fredricks Journal: PLoS One Date: 2013-10-24 Impact factor: 3.240
Authors: Agnieszka Latka; Leen Van Simaey; Marijke Reynders; Piet Cools; Tess Rogier; Barbara Lebbe; Lorenzo Corsini; Christine Landlinger; Mario Vaneechoutte Journal: Antibiotics (Basel) Date: 2022-01-15