Abstract | BACKGROUND: METHODS: 132 women with bacterial vaginosis were randomized 1:1:1:1 to Astodrimer 0.5% (N = 34), 1% (N = 33), or 3% (N = 32) Gel or hydroxyethyl cellulose placebo gel (N = 33) at a dose of 5 g vaginally once daily for 7 days at 6 centers in the United States. The primary endpoint was clinical cure (no bacterial vaginosis vaginal discharge and no more than one of 1) vaginal pH ≥4.5; 2) ≥20% clue cells; or 3) positive whiff test) at study days 21-30. Secondary analyses included clinical cure at study days 9-12, patient-reported symptoms, acceptability and adverse events. RESULTS: The Astodrimer 1% Gel dose was superior to placebo for the primary and selected secondary efficacy measures in the modified intent-to-treat population. Clinical cure rates at day 9-12 were superior to placebo for the Astodrimer 3%, 1% and 0.5% Gel groups (62.5% [15/24; P = .002], 74.1% [20/27; P < .001], and 55.2% [16/29; P = .001], respectively, vs. 22.2% [6/27]). At day 21-30, clinical cure rates were 46.2% (12/26) for the 1% dose vs. 11.5% for placebo (3/26; P = .006). A greater proportion of patients reported absence of vaginal discharge and vaginal odor at day 9-12 and day 21-30 for Astodrimer Gel groups compared with placebo. Adverse events considered potentially treatment-related occurred in only 25% of Astodrimer Gel-treated patients vs. 22% of placebo patients. CONCLUSION:
Astodrimer Gel once daily for 7 days was superior to placebo for treatment of bacterial vaginosis and was well-tolerated. The 1% dose consistently showed the strongest efficacy across endpoints. These results support a role for Astodrimer Gel, 1%, as an effective treatment for bacterial vaginosis.
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Authors | Arthur S Waldbaum, Jane R Schwebke, Jeremy R A Paull, Clare F Price, Stephanie R Edmondson, Alex Castellarnau, Philip McCloud, George R Kinghorn |
Journal | PloS one
(PLoS One)
Vol. 15
Issue 5
Pg. e0232394
( 2020)
ISSN: 1932-6203 [Electronic] United States |
PMID | 32365097
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Bacterial Agents
- Dendrimers
- Gels
- Polylysine
- astodrimer
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Topics |
- Administration, Intravaginal
- Adult
- Anti-Bacterial Agents
(administration & dosage, adverse effects)
- Dendrimers
(administration & dosage, adverse effects)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Administration Schedule
- Female
- Gels
- Humans
- Polylysine
(administration & dosage, adverse effects)
- Treatment Outcome
- Vaginal Discharge
(drug therapy)
- Vaginosis, Bacterial
(drug therapy)
- Young Adult
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