Safety, tolerance and acceptability of the Invisible Condom® and its vaginal applicator in healthy women and their male sexual partners

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