Laboratoire de Santé Hygiène Mobile, Ministry of Public Health and Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.
Contraception. 2010 Jan;81(1):79-85. doi: 10.1016/j.contraception.2009.07.002.
Invisible Condom gel formulations being developed as microbicides to prevent the sexual transmission of HIV are advancing through the phases of clinical trials. The objectives of this study were to evaluate, after 8 weeks of vaginal application, the extended safety and acceptability of two Invisible Condom vaginal gel formulations: (i) the polymer alone and (ii) the polymer containing sodium lauryl sulfate (SLS) compared to placebo.
This study is a randomized, doubled-blind, placebo-controlled Phase II extended safety study in healthy sexually active women from Yaoundé, Cameroon. Women were randomized into three gel arms: (i) placebo, (ii) polymer alone and (iii) polymer/SLS. Women applied gel intravaginally twice daily for 8 weeks.
A total of 194 sexually active women applied placebo (n=41), polymer alone (n=76) and polymer/SLS (n=77). Invisible Condom gel formulations were well tolerated with no reported serious adverse events. The majority of reported adverse events were mild or moderate and mostly similar in all three arms, except for pelvic pain that was 10% higher in the polymer and polymer/SLS arms compared to placebo. Colposcopy showed neither genital ulceration nor mucosal lesions. Nugent score, H(2)O(2)-producing lactobacilli and vaginal pH were not affected by the study products. The gel formulations and applicator were generally acceptable and comfortable.
This extended safety study showed that the Invisible Condom gel formulations and applicator were well tolerated and acceptable when applied intravaginally twice daily for 8 weeks. Thus, further phases of clinical development of Invisible Condom as a potential microbicide to prevent sexual transmission of HIV are warranted.
隐形避孕套凝胶制剂作为杀微生物剂，旨在预防艾滋病毒的性传播，目前正在临床试验的各阶段推进。本研究的目的是评估两种隐形避孕套阴道凝胶制剂（i）聚合物单独使用，（ii）聚合物与十二烷基硫酸钠（SLS）共同使用在阴道应用 8 周后的安全性和可接受性，与安慰剂相比。
这是一项在喀麦隆雅温得的健康活跃女性中进行的随机、双盲、安慰剂对照的 II 期延长安全性研究。女性被随机分为三个凝胶组：（i）安慰剂、（ii）聚合物单独使用和（iii）聚合物/ SLS。女性每天阴道内应用凝胶两次，持续 8 周。
共有 194 名活跃的性活跃女性应用了安慰剂（n=41）、聚合物单独使用（n=76）和聚合物/ SLS（n=77）。隐形避孕套凝胶制剂耐受性良好，无严重不良事件报告。大多数报告的不良事件为轻度或中度，在所有三组中相似，除了盆腔疼痛，聚合物和聚合物/ SLS 组比安慰剂组高 10%。阴道镜检查未发现生殖器溃疡或粘膜病变。阴道 pH 值、产过氧化氢的乳酸杆菌和阴道 pH 值不受研究产品的影响。凝胶制剂和给药器通常是可接受和舒适的。
这项延长安全性研究表明，隐形避孕套凝胶制剂和给药器在阴道内每日应用两次，持续 8 周时耐受性良好，可接受。因此，有必要进一步开展隐形避孕套作为预防艾滋病毒性传播的潜在杀微生物剂的临床开发。
