CCTN - MALE CONTRACEPTIVE - DMAU 28 DAY STUDY

进行一项剂量为28天重复剂量的I期临床试验，以测试十一酸二甲雄酮是否耐受性良好，并将抑制促性腺激素以抑制精子生成。 该试验的目的是在I期临床试验中确定新的口服剂量的 化学物质十一酸二甲雄酮将被很好地耐受，如果重复剂量超过 28天将有效地抑制促性腺激素。第一阶段试验的结果将 确定是否可以在长期的精子抑制临床试验中对这些药物进行评估， 根据获得FDA作为避孕药的批准。因此，这项任务的目标是 命令是进行研究，以便I期临床试验的总体目标是 成功实现。

Conduct a Phase I clinical trial of dose ranging 28 day repeat dose to test wheter Dimethandrolone undecanoate will be well tolerated and will supress gonadotropins to supress spermatogenesis. The objective ofthe trial is to determine, in a Phase I clinical trial, whether oral doses of a new chemical entity, Dimethandrolone undecanoate, will be well tolerated and if repeated dosing over 28 days will be effective in suppressing gonadotropins. Results from the Phase I trial will establish ifthe agents could be evaluated in a longer-term sperm suppression clinical trial, pursuant to obtaining FDA approval as a contraceptive. Therefore, the objective of this Task Order is to conduct the study so that the overall objectives of the Phase I clinical trial are successfully achieved.