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 该任务订单用于进行一项I期临床试验，以测试二甲基雄酮 十一酸的耐受性很好，会抑制促性腺激素。初步结果来自 动物研究表明，口服这种药物既有孕激素又有雄激素活性，而且 会充分抑制促性腺激素，达到抑制精子发生的程度。 由于这项研究是首次在人类身上进行，尚不知道什么剂量的药物会对抑制有效 促性腺激素或药物的耐受性是否良好。这项研究将测试单剂量的药物 男性，并将继续单剂递增强度假设药物是好的 被容忍了。主要结果将是测量促性腺激素在 治疗期间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.