Two phase 3, double-blind, placebo-controlled studies of the efficacy and safety of Astodrimer 1% Gel for the treatment of bacterial vaginosis.
Eur J Obstet Gynecol Reprod Biol
; 245: 13-18, 2020 Feb.
Article
en En
| MEDLINE
| ID: mdl-31812702
ABSTRACT
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. STUDYDESIGN:
Women with bacterial vaginosis were randomized 11 to Astodrimer 1 % Gel (Study 1 conducted in the United States, Nâ¯=â¯127; Study 2 conducted in the United States, Germany and Belgium, Nâ¯=â¯128) or placebo gel (Study 1, Nâ¯=â¯123; Study 2, Nâ¯=â¯123) at a dose of 5â¯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 αâ¯=â¯.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, Pâ¯<â¯.001) (Study 1) and 56.7 % (68/120) vs 21.4 % (25/117, Pâ¯<â¯.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, Pâ¯=â¯.004) (Study 1) and 13.3 % (16/120) vs 5.1 % (6/117, Pâ¯=â¯.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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
1_ASSA2030
Problema de salud:
1_doencas_nao_transmissiveis
Asunto principal:
Polilisina
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Vaginosis Bacteriana
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Dendrímeros
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Antibacterianos
Tipo de estudio:
Clinical_trials
Límite:
Adolescent
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Adult
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Aged
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Aged80
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Female
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Humans
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Middle aged
Idioma:
En
Revista:
Eur J Obstet Gynecol Reprod Biol
Año:
2020
Tipo del documento:
Article
País de afiliación:
Estados Unidos