SPECIALIZED CONTRACEPTIVE DEVELOPMENT RESEARCH CENTER

U54合作专门避孕研究中心资助 本提案中描述的由四项研究和开发组成 项目和一个核心实验室。它的长期、广泛的目标是 提案是增加登记的避孕药具的数量 用于计划生育方案，完成新的开发 与现有方法相比具有特定优势的避孕药具，并 确定可发展为安全有效方法的新线索 对男人和女人来说。具体地说，避孕环具有 已设计用于提供炔诺酮醋酸酯(净Ac)和 乙炔雌二醇(EE)将接受测试，并在美国FDA注册。 剂量发现研究将在完成时预期最终的 RING将提供1毫克的净AC和15或20杯的EE，可供3至 四个月。这枚戒指将通过以下方式提供更好的怀孕保护 抑制排卵，并提供更好的出血控制 提供类似低剂量类固醇的避孕药。少校 这种方法的优点是它提供了一种受控释放系统 用于可由用户自己控制的非肠道类固醇输送 并且不依赖医务人员进行插入和移除。一个 提供LHRH类似物的植入物正在为男性开发。既然是这样 这种方法将同时抑制精子发生和睾酮的产生， 雄激素替代将是这种方法的一个基本特征。因此，一个 植入物将产生新型雄激素7α-甲基- 19去甲睾酮一年的使用情况正在调查中。会是 与提供LHRH激动剂的植入物一起使用。这两个人- 植入系统将提供一种方便的一年避孕方法 并将对前列腺提供额外的健康促进作用。 最后，也防止性传播的避孕方法 疾病变得越来越重要。可能保护人体免受病毒侵害的化合物 艾滋病毒和/或衣原体以及抑制精子发生将是 已确认身份。将为动物试验设计适当的配方 接下来是对女性的研究。这将为女性提供一种保护 自己抗击性传播疾病，而不必 协商使用避孕套，这对许多女性来说是困难的。

The U54 Cooperative Specialized Contraceptive Research Center Grant described in this proposal is comprised of four research and development project and one core laboratory. The long-term, broad objectives of this proposal are to increase the number of contraceptives that are registered for use in family planning programs, to complete the development of new contraceptives with specific advantages over existing methods, and to identify new leads that can be developed into safe and effective methods for men and women. Specifically, a contraceptive vaginal ring that has been designed to deliver norethindrone acetate (NET Ac) and ethynylestradiol (EE) will be tested and registered with the U.S. FDA. Dose-finding studies will be completed with the expectation that the final ring will deliver 1 mg of NET Ac and either 15 or 20 mug of EE for three to four months. This ring will provide better protection against pregnancy by inhibiting ovulation and will provide better bleeding control than contraceptive pills that deliver similar low doses of steroids. The major advantages of this method are that it provides a controlled release system for parenteral steroid delivery that can be controlled by the user herself and does not depend upon medical personnel for insertion and removal. An implant that delivers LHRH analogs is being developed for men. Since this method will suppress both permatogenesis and testosterone production, androgen replacement will be an essential feature of this method. Thus, an implant that will deliver the novel androgen 7alpha-methyl- 19nortestosterone (MENT) for one year is under investigation. It will be used in conjunction with the implant delivering an LHRH agonist. This two- implant system will provide a convenient one-year contraceptive method for men and will provide an additional health-promoting effect on prostate. Finally, contraceptive methods that also prevent sexually transmitted diseases gain increasing importance. Compounds that may protect against HIV and/or chlamydia as well as suppress spermatogenesis will be identified. Appropriate formulations will be designed for animal testing followed by studies in women. This will offer women a method of protecting themselves against sexually transmitted diseases without having to negotiate condom use which is difficult for many women.