Abstract
The objective of the study was to confirm the efficacy and safety of Astodrimer 1% Gel to prevent recurrence of bacterial vaginosis. 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. 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. 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.
Highlights
Birth, and acquisition and transmission of human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) [3,4]
A total of 864 women were enrolled in the open-label phase of the study to receive metronidazole; 586/864 (67.8 %) eligible women entered the double-blind treatment phase and were randomized to either Astodrimer 1% Gel (N = 295) or placebo (N = 291) at 67 sites in the US, 4 in Canada, 4 in Mexico and 2 in Puerto Rico
8.5 % of patients were lost to follow-up compared with 10.3 % of patients in the placebo group
Summary
This was a phase 3, double-blind, multicenter, randomized, placebo-controlled study assessing the efficacy and safety of Astodrimer 1% Gel applied vaginally for 16 weeks compared with placebo (hydroxyethyl cellulose placebo gel) to prevent BV recurrence (Fig. 2).The study complied with the Declaration of Helsinki, was conducted in accordance with Good Clinical Practice, regulatory guidelines, and relevant local legislation, and was approved by an institutional review board on June 20, 2014 (Quorum Review, Inc.). This was a phase 3, double-blind, multicenter, randomized, placebo-controlled study assessing the efficacy and safety of Astodrimer 1% Gel applied vaginally for 16 weeks compared with placebo (hydroxyethyl cellulose placebo gel) to prevent BV recurrence (Fig. 2). Patient enrolment commenced October 2014 with last follow-up in February 2017. Patients provided written informed consent and were screened for eligibility at the Screening visit. Eligible patients with a current symptomatic episode of BV and a history of recurrent BV were enrolled in an open-label phase and received oral metronidazole (500 mg), twice daily for 7 days. At the second visit (Baseline), 3–5 days after completion of metronidazole, women with resolution of BV were randomized 1:1 to either Astodrimer 1% Gel or placebo using a computer-generated randomization list based upon a permutation block procedure
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