CCTN - MALE CONTRACEPTIVE - DMAU 28 DAY STUDY

进行I期临床试验，剂量范围为28天重复给药，以测试二甲雄龙十一酸酯是否耐受良好，是否会抑制促性腺激素以抑制精子发生。该试验的目的是确定，在男性I期临床试验中，口服剂量的新化学避孕药，二甲雄龙十一酸酯，是否耐受良好，如果重复给药超过28天将有效抑制促性腺激素。I期试验的结果将确定是否可以在获得FDA批准作为避孕药的长期精子抑制临床试验中对药物进行评估。因此，本任务的目标 进行研究的顺序是，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 in men , whether oral doses of a new chemical contraceptive, 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.