Safety and efficacy comparison of two dosing regimens of MetroGel-Vaginal® in the treatment of bacterial vaginosis: a multicenter, randomized, single-blind, parallel comparison

Soper, David E.; Livengood, Charles H.; Sheehan, Kate L.; Fenner, Dee E.; Martens, Mark G.; Nelson, Anita L.; Ismail, M.; Thorp, John M.; Lappin, M. R.; Fleury, Frederick J.; Long, Barbara; Blackwelder, Theodore; Sweet, Richard L.; Sagov, Stanley

doi:10.1016/s1068-607x(98)00032-8

Cited by 7 publications

(3 citation statements)

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“… 12 , 17 , 18 The criteria for cure are further impacted by differences in time points of assessment, which ranged from 1 to 5 weeks across studies. 17 , 19 , 20 Adopting more standardized methods for establishing cure may help in identifying agents that can produce more sustained cure rates in women with BV. 21 …”

Section: Discussionmentioning

confidence: 99%

A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Metronidazole Vaginal Gel 1.3% in the Treatment of Bacterial Vaginosis

Schwebke¹,

Marrazzo²,

Beelen³

et al. 2015

Sexually Transmitted Diseases

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Section: Discussionmentioning

confidence: 99%

A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Metronidazole Vaginal Gel 1.3% in the Treatment of Bacterial Vaginosis

Schwebke¹,

Marrazzo²,

Beelen³

et al. 2015

Sexually Transmitted Diseases

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“… 8 In clinical studies, metronidazole vaginal gel (MVG) 0.75% dosed once daily for 5 days was as effective as MVG 0.75% dosed twice daily for 5 days and had a similar safety profile. 9 , 10 Metronidazole vaginal gel 0.75%, applied once or twice daily for 5 days, is approved by the US Food and Drug Administration for the treatment of patients with BV. A new formulation of MVG offers a higher concentration of metronidazole (1.3%) with a shorter treatment course and similar efficacy as MVG 0.75%.…”

mentioning

confidence: 99%

Metronidazole Vaginal Gel 1.3% in the Treatment of Bacterial Vaginosis

Chavoustie

Jacobs

Reisman

et al. 2015

Journal of Lower Genital Tract Disease

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“…A total of five controlled clinical studies evaluating the efficacy of metronidazole vaginal gel 0.75% have been conducted. 1,[15][16][17][18] These trials included the following study designs: 1) a randomized, single-blind controlled trial of metronidazole vaginal gel 0.75% daily vs. twicedaily dosing; 2) a randomized, single-blind controlled trial of metronidazole vaginal gel 0.75% (twice-daily dosing regimen) vs. 500 mg of oral metronidazole twice daily for 7 days; 3) Two randomized, double-blind, placebo-controlled trials of metronidazole vaginal gel 0.75% (twice-daily dosing); 4) a randomized, double-blind, controlled trail of metronidazole vaginal gel 0.75% (twice-daily dosing) vs. triple sulfa cream.…”

Section: Clinical Applicationsmentioning

confidence: 99%

Metronidazole Vaginal Gel 0.75% (MetroGel‐Vaginal^®): A Brief Review

Wain

1998

Infectious Diseases in Obstetrics and Gynecology

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MECHANISM OF ACTIONMetronidazole is a small uncharged molecule that exerts its biologic activity through reduction of its nitro group.3 Anaerobic or microaerophilic conditions promote activation of metronidazole. 4 The action of metronidazole is believed to consist of three successive steps: s entry of the drug into target cells, activation by a reduction process, and toxic effects of the reduced product. The reduction of the nitro group of the 5-nitroimidazole results in the formation of toxic derivatives, which kill susceptible bacteria by interacting with DNA. 4,5 The reduction of metronidazole in anaerobic organisms most likely occurs in a one-electron step and is assumed to lead first to the formation of a free radical anion. 4,5 The proposed site of metronidazole reduction is the pyruvate phosphoroclastic reaction in which feredoxin serves as the terminal electron acceptor. 4,s This process, and thus the level of antimicrobial activity, is markedly influenced by the oxygen tension of the environment. PHARMACOKINETICSThe bioavailability of metronidazole varies according to the route of administration. 6 Intravenous or oral administration of metronidazole results in nearly 100% bioavailability, and the drug diffuses readily to nearly all body tissues. 7 Topical administration (rectal or intravaginal) reduces the bioavailability, resulting in lower serum concentrations of the drug. 7,8 Metronidazole is metabolized by the liver into acid and hydroxy metabolites. The hydroxy metabolite is present in plasma in

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Safety and efficacy comparison of two dosing regimens of MetroGel-Vaginal® in the treatment of bacterial vaginosis: a multicenter, randomized, single-blind, parallel comparison

Cited by 7 publications

References 0 publications

A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Metronidazole Vaginal Gel 1.3% in the Treatment of Bacterial Vaginosis

A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Metronidazole Vaginal Gel 1.3% in the Treatment of Bacterial Vaginosis

Metronidazole Vaginal Gel 1.3% in the Treatment of Bacterial Vaginosis

Metronidazole Vaginal Gel 0.75% (MetroGel‐Vaginal^®): A Brief Review

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Safety and efficacy comparison of two dosing regimens of MetroGel-Vaginal® in the treatment of bacterial vaginosis: a multicenter, randomized, single-blind, parallel comparison

Cited by 7 publications

References 0 publications

A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Metronidazole Vaginal Gel 1.3% in the Treatment of Bacterial Vaginosis

A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Metronidazole Vaginal Gel 1.3% in the Treatment of Bacterial Vaginosis

Metronidazole Vaginal Gel 1.3% in the Treatment of Bacterial Vaginosis

Metronidazole Vaginal Gel 0.75% (MetroGel‐Vaginal®): A Brief Review

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Metronidazole Vaginal Gel 0.75% (MetroGel‐Vaginal^®): A Brief Review