CCTN - MALE CONTRACEPTIVE TRIAL DMAU-SEDDS STUDY

进行单剂量新药二甲雄龙十一酸酯的I期临床试验。 本任务指令用于进行I期临床试验，以测试十一酸二甲雄龙是否具有良好的耐受性并抑制促性腺激素。动物研究的初步结果表明，口服或肌内注射本品具有促性腺激素和雄激素活性，并将充分抑制促性腺激素至抑制精子发生的水平。肌内给药可能具有长效效果。由于这项研究是首次在男性IM交付，目前还不知道什么剂量的药物将是有效的抑制促性腺激素或药物是否会被良好耐受。该研究将在男性中测试单剂量药物，并将继续单剂量递增强度，假设药物耐受性良好。主要结局将是测量治疗期间促性腺激素的抑制，并收集有关可能的副作用的信息。 本试验的目的是在I期临床试验中确定肌内给药是否 一个新的化学实体，二甲雄龙十一酸酯，将在一个单一的剂量耐受良好 递增研究I期试验的结果将确定这些药物是否可以在临床试验中进行评估。 长期的精子抑制临床试验，根据获得FDA批准作为一种 避孕药因此，本工作指令的目的是进行研究， I期临床试验的总体目标成功实现。

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.