Abstract:
BACKGROUND:Bacterial vaginosis (BV), a prevalent infection in women of reproductive age, is associated with increased risk of upper genital tract and sexually transmitted infections, and complications in pregnancy. Currently approved treatments include metronidazole, which requires once or twice daily intravaginal administration for 5 days or twice daily oral administration for 7 days. This phase 3 study determined the safety and efficacy of single-dose metronidazole vaginal gel (MVG) 1.3%. METHODS:In this double-blind, vehicle-controlled study, 651 women with clinical diagnosis of BV were randomized 1:1 to receive MVG 1.3% or vehicle vaginal gel. Primary efficacy measure was clinical cure (normal discharge, negative "whiff test," and <20% clue cells) at day 21. Secondary measures included therapeutic cure (both clinical and bacteriological; day 21) and bacteriologic cure (Nugent score <4), clinical cure, and time to resolution of symptoms (day 7). RESULTS:A total of 487 participants were included in the primary analysis. Clinical and therapeutic cure rates (day 21) were higher in participants treated with MVG 1.3% compared with vehicle gel (37.2% vs. 26.6% [P = 0.010] and 16.8% vs. 7.2% [P = 0.001], respectively). Clinical and bacteriologic cure rates (day 7) were also higher in the MVG 1.3% group (46.0% vs. 20.0% [P < 0.001] and 32.7% vs. 6.3% [P < 0.001], respectively). The median time to resolution of symptoms was shorter in the MVG 1.3% (day 6) than vehicle group (not reached). No serious adverse events were reported, and incidence was similar across treatment groups. CONCLUSIONS:Single-dose MVG 1.3% was safe and superior to vehicle gel in producing cure among women with BV.
journal_name
Sex Transm Disjournal_title
Sexually transmitted diseasesauthors
Schwebke JR,Marrazzo J,Beelen AP,Sobel JDdoi
10.1097/OLQ.0000000000000300subject
Has Abstractpub_date
2015-07-01 00:00:00pages
376-81issue
7eissn
0148-5717issn
1537-4521pii
00007435-201507000-00005journal_volume
42pub_type
杂志文章,多中心研究,随机对照试验abstract:BACKGROUND:The objective of this study was to analyze the proportion of herpes simplex virus types 1 and 2 (HSV-1 and HSV-2) in genital infections during a 10-year period (2003-2012) among outpatients of a clinic of sexually transmitted disease in Southwestern Finland. METHODS:We analyzed prospectively the proportion ...
journal_title:Sexually transmitted diseases
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journal_title:Sexually transmitted diseases
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journal_title:Sexually transmitted diseases
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abstract:OBJECTIVES:This study assessed whether participant baseline characteristics modified the effects of a skill-based intervention promoting condom use. STUDY:The randomized, controlled trial enrolled 427 women from a sexually transmitted disease clinic in Birmingham, Alabama. The main outcome measures: consistent (100%) ...
journal_title:Sexually transmitted diseases
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abstract::Disclosure of sexually transmitted infections (STIs) to sexual partners is critical to the prevention, treatment, and control of STIs. We examine personal intra and interpersonal influences on willingness to disclose STI status among college-aged men. Participants (n = 1064) were aged 17 to 24 years and recruited from...
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journal_title:Sexually transmitted diseases
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更新日期:2007-03-01 00:00:00
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journal_title:Sexually transmitted diseases
pub_type: 杂志文章
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更新日期:2020-09-01 00:00:00
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journal_title:Sexually transmitted diseases
pub_type: 杂志文章,多中心研究
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pub_type: 杂志文章
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journal_title:Sexually transmitted diseases
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