CCTN - CONTRACEPTIVE CLINICAL TRIALS - MALE SITES, DMAU

CCTN - 避孕临床试验 - 男性站点、DMAU

• 批准号: 10002024
• 负责人: CHRISTINA WANG
• 金额: $ 40.28万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-01-13 至 2021-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10002024
• 关键词: Admission activity; Androgens; Animals; Chemicals; Clinical Research; Clinical Trials; Contraceptive Agents; Contraceptive History; Dose; Drug Delivery Systems; Eligibility Determination; Enrollment; Fasting; Formulation; Gonadotropins; Informed Consent; Interview; Laboratories; Male Contraceptive Agents; Measures; Medical History; Oral; Pharmaceutical Preparations; Phase; Phase I Clinical Trials; Physical Examination; Procedures; Progestins; Protocols documentation; Randomized; Reproductive History; Schedule; Site; Specific qualifier value; Specimen; Spermatogenesis; Testing; Visit; demographics; eligible participant; first-in-human; male; man; men; overtreatment; phase I trial; primary outcome; recruit; screening; side effect; sperm cell; treatment duration

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.

男性避孕试验DMAU与自乳化药物递送系统（SEDDS） 本任务指令用于进行I期临床试验，以测试二甲双胍。 十一酸盐耐受性良好，并抑制促性腺激素。的初步结果 动物研究表明，口服剂量的药物具有促性腺激素和雄激素活性， 将充分抑制促性腺激素到产生精子发生抑制的水平。 由于这项研究是首次在人类中进行，因此尚不清楚什么剂量的药物将有效抑制 促性腺激素或药物是否耐受良好。该研究将测试单剂量药物， 男性，并将继续与单剂量的不断升级的力量，假设药物是好的， 容忍。主要结果将是测量促性腺激素的抑制， 治疗期间，并收集有关可能的副作用的信息。