864 women with a diagnosis of
bacterial vaginosis and a history of recurrent
bacterial vaginosis were enrolled in North America and first received oral
metronidazole (500 mg twice daily for 7 days). Women successfully treated with
metronidazole were randomly assigned 1:1 to
Astodrimer 1% Gel (N = 295) or placebo (N = 291) at a dose of 5 g vaginally every second day for 16 weeks, and followed for a further 12 weeks off-treatment. The primary endpoint was recurrence of
bacterial vaginosis (presence of ≥3 Amsel criteria) at or by Week 16. Secondary endpoints included time to recurrence, and recurrence of subject-reported symptoms. Adverse events were monitored throughout the study.
RESULTS:
Astodrimer 1% Gel was superior to placebo for the primary and many secondary efficacy measures. At or by Week 16,
bacterial vaginosis recurred in 44.2 % (130/294) of women receiving
astodrimer and 54.3 % (158/291) receiving placebo (P = .015). Time to recurrence of
bacterial vaginosis was significantly longer for women receiving
astodrimer compared with placebo (Kaplan-Meier survival curves, P = .007). Recurrence of subject-reported symptoms at or by Week 16 was also significantly lower in the
astodrimer arm compared with placebo (vaginal odor and/or discharge, 27.9 % [75/269] vs 40.6 % [108/266], P = .002). A significantly lower proportion of patients receiving
astodrimer compared with placebo had recurrence of
bacterial vaginosis at or by Week 16 by other secondary measures, including individual Amsel criteria (
vaginal discharge and clue cells) and Nugent score 7-10. Recurrence of subject-reported vaginal odor and/or discharge was significantly lower in the
astodrimer arm compared with placebo up to 8 weeks after cessation of
therapy (36.1 % [97/269] vs 45.5 % [121/266], P = .027).Adverse events were infrequent, and rates were generally similar between placebo and
astodrimer groups.
Vulvovaginal candidiasis and
urinary tract infection occurred more often in women receiving
astodrimer.
CONCLUSIONS:
Astodrimer 1% Gel, administered every second day for 16 weeks, was effective and superior to placebo for prevention of recurrent
bacterial vaginosis in women with a history of recurrent BV, and was well-tolerated.