Two phase 3, double-blind, placebo-controlled studies of the efficacy and safety of Astodrimer 1% Gel for the treatment of bacterial vaginosis.
OBJECTIVE
Astodrimer is a dendrimer formulated in a vaginal gel to treat bacterial vaginosis (BV) and prevent recurrence. The objective of these studies was to confirm the efficacy and safety of Astodrimer 1 % Gel for treatment of BV.


STUDY DESIGN
Women with bacterial vaginosis were randomized 1:1 to Astodrimer 1 % Gel (Study 1 conducted in the United States, N = 127; Study 2 conducted in the United States, Germany and Belgium, N = 128) or placebo gel (Study 1, N = 123; Study 2, N = 123) at a dose of 5 g vaginally once daily for 7 days. The primary endpoint was clinical cure, defined as i) absence of bacterial vaginosis vaginal discharge; ii) <20 % clue cells; and iii) negative whiff test at day 9-12. Secondary efficacy analyses included clinical cure at day 21-30. Other endpoints at days 9-12 and 21-30 included Nugent cure (Nugent score ≤3), absence of symptoms, and adverse events. The primary analysis in the modified intent-to-treat population used the Cochran Mantel Haenszel test stratified by analysis center with a two-sided significance level of α = .05.


RESULTS
Astodrimer 1 % Gel was superior to placebo for the primary and selected secondary efficacy measures. Clinical cure rates at day 9-12 were 50.4 % (59/117) vs 16.5 % (19/115, P < .001) (Study 1) and 56.7 % (68/120) vs 21.4 % (25/117, P < .001) (Study 2) for astodrimer vs placebo. At day 21-30, clinical cure results showed a similar trend but the difference to placebo was not statistically significant. Nugent cure rates at day 9-12 were 12.8 % (15/117) vs 2.6 % (3/115, P = .004) (Study 1) and 13.3 % (16/120) vs 5.1 % (6/117, P = .030) (Study 2) for astodrimer vs placebo. A greater proportion of women receiving astodrimer reported absence of vaginal discharge and absence of vaginal odor at day 9-12 and day 21-30 compared with placebo. Adverse events were generally mild and self-limiting. For the combined studies, adverse events potentially related to treatment occurred in 14.7 % (37/252) of astodrimer patients vs 9.4 % (23/244) for placebo, including vulvovaginal candidiasis reported for 2.4 % (6/252) of astodrimer patients.


CONCLUSION
These results support a role for Astodrimer 1 % Gel as an effective, safe and well-tolerated treatment for women with bacterial vaginosis.
['Chavoustie|Steven E|SE|', 'Carter|Belvia A|BA|', 'Waldbaum|Arthur S|AS|', 'Donders|Gilbert G G|GGG|', 'Peters|Klaus H|KH|', 'Schwebke|Jane R|JR|', 'Paull|Jeremy R A|JRA|', 'Price|Clare F|CF|', 'Castellarnau|Alex|A|', 'McCloud|Philip|P|', 'Kinghorn|George R|GR|']
D000282:Administration, Intravaginal D000293:Adolescent D000328:Adult D000368:Aged D000369:Aged, 80 and over D000900:Anti-Bacterial Agents D018441:Biofilms D050091:Dendrimers D004311:Double-Blind Method D005260:Female D006801:Humans D057194:Intention to Treat Analysis D008875:Middle Aged D011107:Polylysine D016896:Treatment Outcome D014621:Vagina D014622:Vaginal Creams, Foams, and Jellies D016585:Vaginosis, Bacterial D055815:Young Adult
Treatment Bacterial vaginosis Dendrimer Astodrimer gel Biofilm SPL7013 VivaGel®