CCTN - MALE CONTRACEPTIVE - DMAU 28 DAY STUDY

CCTN - 男性避孕 - DMAU 28 天研究

• 批准号: 8937262
• 负责人: CHRISTINA WANG
• 金额: $ 93.04万
• 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: 2014-09-30 至 2016-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8937262
• 关键词: Admission activity; Adverse event; Blood; Chemicals; Clinical; Clinical Trials; Contraceptive Agents; Contraceptive History; Contractor; Data; Data Collection; Dose; Eligibility Determination; Enrollment; Event; Gonadotropins; Health; Hormones; Informed Consent; Interview; Laboratories; Male Contraceptive Agents; Measurement; Measures; Medical History; National Institute of Child Health and Human Development; Oral; Patients; Pharmaceutical Preparations; Phase I Clinical Trials; Physical Examination; Procedures; Protocols documentation; Questionnaires; Randomized; Recruitment Activity; Regimen; Reproductive History; Sampling; Schedule; Seminal fluid; Serious Adverse Event; Shipping; Ships; Specific qualifier value; Specimen; Spermatogenesis; Telephone; Testing; Text; Time; Urine; Visit; Writing; base; demographics; diaries; eligible participant; follow-up; man; meetings; men; response; screening; sperm cell; transmission process

Conduct a Phase I clinical trial of dose ranging 28 day repeat dose to test wheter Dimethandrolone undecanoate will be well tolerated and will supress gonadotropins to supress spermatogenesis. The objective ofthe trial is to determine, in a Phase I clinical trial, whether oral doses of a new chemical entity, Dimethandrolone undecanoate, will be well tolerated and if repeated dosing over 28 days will be effective in suppressing gonadotropins. Results from the Phase I trial will establish ifthe 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.

进行I期临床试验，剂量范围为28天重复给药，以测试二甲雄龙十一酸酯是否耐受良好，是否会抑制促性腺激素以抑制精子发生。 本试验的目的是确定，在I期临床试验中， 化学实体，二甲雄龙十一酸酯，将被良好耐受，如果重复给药超过 28天将有效抑制促性腺激素。I期试验的结果将 确定这些药物是否可以在长期的精子抑制临床试验中进行评估， 作为避孕药获得FDA批准。因此，本任务的目标 进行研究的顺序是，I期临床试验的总体目标是 成功实现。