SPECIALIZED CONTRACEPTIVE DEVELOPMENT RESEARCH CENTER

U 54专业避孕研究合作中心赠款 本提案中所述的是由四个研究和开发 项目和一个核心实验室。 长期的、广泛的目标 建议增加登记的避孕药具数量 用于计划生育方案，以完成新的发展， 与现有方法相比具有特定优势的避孕药具， 确定可发展为安全有效方法的新线索 对于男人和女人来说。 具体来说，一种避孕阴道环， 被设计用于递送醋酸炔诺酮（NET Ac）， 乙炔基甜菜碱（EE）将在美国FDA进行测试和注册。 将完成剂量探索研究，预计最终剂量将达到 环将提供1毫克的净Ac和15或20杯EE的三个， 四个月 这种戒指将提供更好的保护，防止怀孕， 抑制排卵，并将提供更好的出血控制， 提供类似低剂量类固醇的避孕药。 主要 该方法的优点在于它提供了一种控释系统 对于可由使用者自己控制的非肠道类固醇递送 并且不依赖于医务人员进行插入和移除。 一个 正在开发用于男性的递送LHRH类似物的植入物。 由于这 该方法将抑制精子发生和睾酮产生， 雄激素替代将是该方法的基本特征。 因此， 植入物，将提供新的雄激素7 α-甲基- 19去甲睾酮（MENT）一年的研究正在进行中。 将 与递送LHRH激动剂的植入物结合使用。 这两个- 植入系统将提供一种方便一年避孕方法， 男性，并将提供一个额外的健康促进作用的前列腺。 最后，避孕方法，也防止性传播 疾病变得越来越重要。 可以防止 艾滋病毒和/或衣原体以及抑制精子发生将是 鉴定 将设计适当的制剂用于动物试验 其次是女性研究。 这将为女性提供一种保护 预防性传播疾病，而不必 协商使用避孕套，这对许多女性来说很困难。

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.