کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
3915792 1251521 2007 9 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Safety, tolerance and acceptability of the Invisible Condom® and its vaginal applicator in healthy women and their male sexual partners
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی زنان، زایمان و بهداشت زنان
پیش نمایش صفحه اول مقاله
Safety, tolerance and acceptability of the Invisible Condom® and its vaginal applicator in healthy women and their male sexual partners
چکیده انگلیسی

ObjectivesThe study was conducted to evaluate the safety and acceptability of the Invisible Condom® when applied once or twice daily for 14 days in healthy women and their male sexual partners.Study DesignForty-one women and 23 men divided into three cohorts were enrolled. Cohort 1: 14 sexually abstinent women applying gel twice daily for 14 days; Cohort 2: 14 sexually active women with tubal ligation applying gel once daily for 14 days and their 14 sexual partners who did not use gel; Cohort 3: 13 women on oral contraceptive applying gel once daily for 14 days and 9 of their sexual partners.ResultsNo serious adverse events (AEs) were reported. Colposcopy showed no genital ulceration nor epithelial lesions. No major changes in vaginal flora or vaginal pH were detected. None of the women had to stop product application because of AEs. The majority of AEs were mild. Common AEs were itching, dryness, burning sensation, erythema and discharge. Satisfaction questionnaire showed that the gel and applicator were acceptable.ConclusionThe Invisible Condom® and applicator were safe, well tolerated and acceptable when applied intravaginally for 14 days. Thus, expanded safety and effectiveness evaluation is warranted.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Contraception - Volume 76, Issue 2, August 2007, Pages 117–125
نویسندگان
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