Safety, and acceptability of a non-hormonal vaginal ring

现代避孕药不仅在防止意外怀孕方面发挥着关键作用，而且还有助于 通过赋予妇女必要的资源来控制其自身的生殖健康，从而增进妇女的福祉。 然而，目前可用的女性避孕药具缺乏一个或多个重要参数，包括 有效性、安全性和可用性，从而使目前可用的避孕组合不是最优的。一次高潮 避孕药市场不断增长的影响驱动因素是意外怀孕的数量，这种情况的风险 当避孕措施使用不正确、不一致或根本不使用时，就会增加。大约190万 2016年，美国报告了意外怀孕事件，这对母亲和 这对儿童造成了伤害，给妇女个人和公众带来了沉重的经济负担。不完全使用 目前可用的避孕选择的减少可归因于一系列障碍，包括不便。 (日常行为或性交时的行为)和与荷尔蒙相关的不良副作用 避孕药。这些缺点表明，需要新的、非激素的避孕选择，这些选择是 方便、易用、高效。为了满足这一需求，DaréBioscience，Inc.正在开发奥瓦平 该装置是一种非荷尔蒙的阴道内环，提供安全有效的每月节育选择。异丙肾上腺素 结合了覆盖宫颈的柔性网状屏障，同时缓慢释放非激素的混合物， 抗精子成分。FDA已经将异丙肾上腺素指定为联合产品，并确定 设备和放射健康中心(CDRH)将是这本小说的主要审查机构 避孕药。这项SBIR提案的目的是展示初步的避孕效果， 单中心、开放标签、无意义的异丙肾上腺素的安全性、活性药物释放概况、接受性和适合性 风险设备研究。初步疗效将通过性交后测试和对任何 在佩戴异丙肾上腺素装置的妇女中，逐渐活动的精子进入宫颈。安全将是 评估超过28天的连续使用。我们还将建立制作后质量控制指标和 收集代理释放数据。成功完成本提案中的所有里程碑将提供 必要的信息来支持一项关键的有效性人体研究--奥伐他林避孕效果 推进FDA对美国市场的审批。

Modern contraceptives not only play a critical role in preventing unplanned pregnancy but also contribute to a woman’s well-being by empowering her with the necessary resources to control her own reproductive health. However, currently available female contraceptives are lacking in one or more important parameters, including effectiveness, safety, and usability, thus rendering the currently available contraceptive mix sub-optimal. A high impact driver of the growing contraceptives market is the number of unintended pregnancies, the risk of which is increased when contraceptives are used incorrectly, inconsistently, or not at all. Approximately 1.9 million unintended pregnancies were reported in the US in 2016, posing a significant medical risk for mothers and children, and placing significant economic burdens on individual women and the general public. Imperfect use of currently available contraceptive options can be attributed to a range of obstacles, including inconvenience (daily action, or action at the time of intercourse) and adverse side effects associated with hormonal contraceptives. These drawbacks demonstrate a need for novel, non-hormonal contraceptive options that are convenient, easy-to-use, and effective. To meet this need, Daré Bioscience, Inc. is developing the Ovaprene® device, a non-hormonal intravaginal ring that provides a safe and effective monthly birth control option. Ovaprene combines a flexible mesh barrier that covers the cervix while slowly releasing a mix of non-hormonal, spermiostatic ingredients. The FDA has already designated Ovaprene as a combination product and determined that the Center for Devices and Radiological Health (CDRH) will be the lead reviewing agency for this novel contraceptive. The objective of this SBIR proposal is to demonstrate the preliminary contraceptive performance, safety, active agent release profile, acceptance, and fit of Ovaprene in a single-center, open-label, non-significant risk device study. Preliminary efficacy will be evaluated by postcoital testing and the measurement of any progressively motile sperm gaining access to the cervix in women wearing the Ovaprene device. Safety will be evaluated over 28 days of continuous use. We will also establish post-production quality control metrics and collect agent release data. The successful accomplishment of all milestones in this proposal will provide necessary information to support a Pivotal efficacy human study of Ovaprene contraceptive effectiveness in advance of FDA clearance for the US market.