Supplement to CLINICAL RESEARCH OF DENDRIMER COMBINATION MICROBICIDES

树枝状聚合物组合杀菌剂临床研究的补充

• 批准号: 7962682
• 负责人: Kathleen Listiak Vincent
• 金额: $ 34.41万
• 依托单位: STARPHARMA, LTD
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-03 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7962682
• 关键词: Address; Administrative Supplement; Animal Model; Area; Back; Clinical Research; Clinical Trials; Colposcopy; Computers; Data; Development; Drug Formulations; Ensure; Environment; Epithelial; Epithelium; Equipment; Face; Floods; Floor; Funding; Furniture; Future; Gynecologist; Housing; Human; Image; Individual; Interruption; Knowledge; Laboratories; Life; Motivation; Nature; Neoplastic Processes; Patients; Pediatric Hospitals; Perception; Productivity; Research; Research Personnel; Resources; Safety; Services; Sewage; Source; Specimen; Telefacsimile; Telephone; Time; Tissues; Toxic effect; U-Series Cooperative Agreements; Vagina; Visit; Water; Woman; Work; cytotoxic; experience; flexibility; foot; in vivo; laptop; meetings; microbicide; programs; response; safety study

This study will explore the usefulness of OCT imaging in assessing the in vivo cytotoxic effects of microbicides on cervicovaginal epithelium. Although OCT has been used in over 350 women to evaluate neoplastic processes, its value in assessing safety of new vaginal products has not been evaluated in humans. We have already demonstrated the potential usefulness of OCT imaging in animal models; this study will extend that to examine the use of OCT in humans. It is also likely to advance our knowledge of the impact of N-9 on the vaginal epithelium. OCT holds great promise for providing a sensitive, non-invasive assessment of tissue integrity that can be used in adjunct to colposcopy. Finally, the study will evaluate the women's motivation and barriers to participation in studies of this nature. Recent clinical trials of microbicides found that women were not adherent to use of the microbicide. Greater information about clinical trial participation may help in the future planning and implementation of microbicide trials .

这项研究将探讨OCT成像在评估体内细胞毒性作用中的有用性 在宫颈阴道上皮上。尽管已在350多名女性中使用了OCT来评估肿瘤 过程，它在评估新阴道产品安全性方面的价值尚未在人类中评估。我们有 已经证明了OCT成像在动物模型中的潜在有用性。这项研究将把它扩展到 检查OCT在人类中的使用。它也可能会提高我们对N-9影响的了解 阴道上皮。 OCT对组织提供敏感的，无创的评估有很大的希望 可用于阴道镜检查的完整性。最后，该研究将评估妇女的动机和 参与这种性质研究的障碍。最近对菌皮剂的临床试验发现女性是 不遵守使用菌心的使用。有关临床试验参与的更多信息可能有助于 未来的计划和实施菌心试验。