کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
3915910 1251524 2007 6 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Fourteen-day safety and acceptability study of the universal placebo gel
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی زنان، زایمان و بهداشت زنان
پیش نمایش صفحه اول مقاله
Fourteen-day safety and acceptability study of the universal placebo gel
چکیده انگلیسی

ObjectiveThis study evaluated the effect of the so-called universal placebo compared to the polystyrene sulfonate (PSS) placebo on genital irritation.DesignA single-center, Phase I, randomized, closed-label study was performed to evaluate the genital irritation of microbicide placebo gels. Thirty healthy, sexually abstinent women were randomly assigned to apply 3.5 mL of either the universal placebo or the PSS placebo gel intravaginally twice daily for 14 days.MethodsGenital irritation was assessed by signs as seen on pelvic examination and colposcopy and reports of symptoms. Vaginal health was assessed by wet mounts, Gram stains for Nugent score and polymorphonuclear leukocytes, and semiquantitative vaginal cultures. Acceptability was assessed as reported on the follow-up questionnaire.ResultsThe universal placebo was less irritating than the PSS placebo with a lower proportion of women experiencing signs and/or symptoms of genital irritation throughout follow-up (36% compared to 80%, p=.0253). The universal placebo was associated with few and mild genital symptoms, few and minor colposcopic findings and good vaginal health with no clinically significant changes in genital flora. Most participants found the feel of the universal placebo gel neutral or pleasant, and all participants found it odorless.ConclusionsThe universal placebo appeared safe and acceptable when used twice daily for 14 days. The strategy of creating a de novo inert universal placebo is a successful approach. The universal placebo is appropriate for use as a placebo gel in HIV prevention trials with microbicide candidates.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Contraception - Volume 75, Issue 2, February 2007, Pages 136–141
نویسندگان
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