CCTN - MALE CONTRACEPTIVE - DMAU 28 DAY STUDY

进行一期临床试验，剂量范围为28天重复剂量，以测试十一酸地美雄龙是否耐受性良好，是否会抑制促性腺激素以抑制精子发生。该试验的目的是在一项男性I期临床试验中确定口服一种新的化学避孕药十一酸地美雄龙是否耐受性良好，如果在28天内重复给药，是否能有效抑制促性腺激素。I期试验的结果将确定这些药物是否可以在长期的精子抑制临床试验中进行评估，以获得FDA批准作为避孕药。因此，本任务的目标

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.