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Title
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Two phase 3, double-blind, placebo-controlled studies of the efficacy and safety of Astodrimer 1% Gel for the treatment of bacterial vaginosis
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Author
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Abstract
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| 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 alpha = .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. (C) 2019 Elsevier B.V. All rights reserved. |
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Language
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English
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Source (journal)
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European journal of obstetrics and gynecology and reproductive biology. - Amsterdam, 1973, currens
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Publication
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Amsterdam
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Elsevier
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2020
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ISSN
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0301-2115
[print]
1872-7654
[online]
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DOI
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10.1016/J.EJOGRB.2019.11.032
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Volume/pages
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245
(2020)
, p. 13-18
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ISI
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000515443300003
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Pubmed ID
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31812702
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Full text (Publisher's DOI)
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Full text (open access)
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Full text (publisher's version - intranet only)
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