CCTN - MALE CONTRACEPTIVE TRIAL DMAU-SEDDS STUDY

进行单剂新药十一酸二甲雄酮的I期临床试验。 这项任务指令是为了进行一项I期临床试验，以测试十一酸二甲雄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，口服或肌肉注射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。肌肉注射给药可能有长期的作用效果。由于这项研究是首次在男性IM中进行的，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，或者该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。 该试验的目的是在I期临床试验中确定肌肉内剂量 一种新的化学物质十一酸二甲雄酮将在单剂中被很好地耐受性 升级研究。第一阶段试验的结果将确定这些药物是否可以在 根据FDA批准的长期精子抑制临床试验 避孕药。因此，本任务令的目标是进行研究，以便 第一阶段临床试验的总体目标顺利实现。

To conduct Phase I clinical trials of single doses of a new drug entity, Dimethandrolone undecanoate. This Task Order is for the conduct of a Phase I clinical trial to test whether Dimethandrolone undecanoate will be well tolerated and will suppress gonadotropins. Preliminary results from animal studies indicate that an oral or an intramuscular dose of the drug has both progestin and androgen activity and will suppress gonadotropins sufficiently to a level that produces inhibition of spermatogenesis. Delivery of the dose intramuscularly may have long acting effectiveness. Since this study is first in man IM delivery, 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. The objective of the trial is to determine, in a Phase I clinical trial, whether intramuscular doses of a new chemical entity, Dimethandrolone undecanoate, will be well tolerated in a single dose escalation study. Results from the Phase I trial will establish if the 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.