Trottier Sylvie, Omar Rabeea F, Désormeaux André, Drouin Jean, Gagnon Marie-Thérèse, Vezina Francine, Guilbert Edith, Mâsse Benoît, Bergeron Michel G
Infectious Diseases Research Centre, Université Laval, Québec, QC, Canada G1V 4G2.
Contraception. 2007 Aug;76(2):117-25. doi: 10.1016/j.contraception.2007.04.015. Epub 2007 Jun 22.
The 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.
Forty-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.
No 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.
The Invisible Condom and applicator were safe, well tolerated and acceptable when applied intravaginally for 14 days. Thus, expanded safety and effectiveness evaluation is warranted.
本研究旨在评估隐形避孕套在健康女性及其男性性伴侣中每日使用一次或两次、持续14天时的安全性和可接受性。
招募了41名女性和23名男性，分为三个队列。队列1：14名禁欲女性，每日使用凝胶两次，共14天；队列2：14名已接受输卵管结扎的性活跃女性，每日使用凝胶一次，共14天，以及她们14名未使用凝胶的性伴侣；队列3：13名口服避孕药的女性，每日使用凝胶一次，共14天，以及她们9名性伴侣。
未报告严重不良事件（AE）。阴道镜检查未发现生殖器溃疡或上皮病变。未检测到阴道菌群或阴道pH值的重大变化。没有女性因不良事件而停止使用该产品。大多数不良事件为轻度。常见的不良事件有瘙痒、干燥、烧灼感、红斑和分泌物。满意度调查问卷显示，凝胶和 applicator是可接受的。
隐形避孕套和 applicator在阴道内使用14天时是安全的，耐受性良好且可接受。因此，有必要进行扩大的安全性和有效性评估。
