CCTN - CONTRACEPTIVE CLINICAL TRIALS - MALE SITES, DMAU

采用自乳化药物释放系统(SEDDS)的男性避孕试验DMAU 这项任务指令是为了进行一项I期临床试验，以测试十一酸二甲基诺酮是否具有良好的耐受性，并将抑制促性腺激素。动物研究的初步结果表明，口服剂量的药物同时具有孕激素和雄激素活性，并将充分抑制促性腺激素，达到抑制精子生成的水平。 由于这项研究是首次在人类身上进行，目前还不知道什么剂量的药物可以有效地抑制促性腺激素，也不知道这种药物是否具有良好的耐受性。这项研究将在男性身上测试单剂量药物，并将继续单剂量递增强度，假设该药物耐受性良好。主要结果将是测量治疗期间促性腺激素的抑制情况，并收集有关可能的副作用的信息。

Male Contraceptive Trial DMAU with Self-Emulsifying Drug Delivery System (SEDDS) This Task Order is for the conduct of a Phase I clinical trial to test whether Dimethand.rolone undecanoate will be well tolerated and will suppress gonadotropins. Preliminary results from animal studies indicate that an oral dose of the drug has both progestin and androgen activity and will suppress gonadotropins sufficiently to a level that produces inhibition of spermatogenesis. Since this study is first in man, it is not known what dose of drug will be effective at suppression of gonadotropins or if the drug will be well tolerated. The study will test a single dose of drug in men and will continue with single doses of escalating strength assuming that the drug is well tolerated. The primary outcome will be to measure suppression of gonadotropins over the treatment period and to collect information about possible side effects.