CLINICAL EVALUATION OF NEW CHEMICAL CONTRACEPTIVES FOR MEN

进行I期临床试验，以测试新化合物如11-β甲基去甲睾酮十二烷基碳酸酯作为男性避孕药是否具有良好的耐受性和抑制促性腺激素。 新化学实体在健康男性中用作避孕药的安全性和耐受性、药代动力学和药效学的临床评价 该任务的目的是通过I期临床研究评估， 新的化学实体，如11-β甲基去甲睾酮十二烷基碳酸酯，将被 安全且耐受良好。初步I期研究的结果将确定药物是否 可以在获得FDA批准后的长期临床试验中进行评估， 避孕药因此，本任务指令的目的是进行临床评价，以便成功实现I期临床研究的总体目标。 办妥了一批

Conduct a Phase I clinicfal trial to test new compounds such as 11-beta methyl nortestoserone dodecylcarbonate will be well tolerated and suppress gonadotrophins as a contraceptive drug for men. Clinical Evaluation of New Chemical Entities for Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics for Use as Contraceptives in Healthy Men The objective of the task is to evaluate via Phase I clinical studies, whether doses of new chemical entities such as 11-beta methyl nortestosterone dodecylcarbonate, will be safe and well tolerated. Results from initial Phase I studies will establish if the agent could be evaluated in longer-term clinical trials pursuant to obtaining FDA approval as a contraceptive. Therefore, the objective of this Task Order is to conduct clinical evaluation so that the overall objectives of the Phase I clinical studies are successfully achieved.