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CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - MALE 28 DAY NES TES

CCTN - 避孕临床试验网络 - 男性 28 天 NES TES

基本信息

批准号：
8937264
负责人：
CHRISTINA WANG
金额：
$ 44.04万
依托单位：
LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-30 至 2016-03-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8937264
关键词：
Admission activity Androgens Attitude Blood specimen Chemistry Clinical Trials Clinical Trials Network Contraceptive Agents Contraceptive History Contraceptive methods Drug Formulations Drug Kinetics Eligibility Determination Enrollment Evaluation Future Gel Gonadotropins Informed Consent Instruction Interview Laboratories Medical History Methods Moods National Institute of Child Health and Human Development Nestorone Pharmaceutical Preparations Pharmacodynamics Phase Physical Examination Pregnancy Preparation Procedures Production Progestins Property Prostate Protocols documentation Randomized Recruitment Activity Regimen Reproductive History Sampling Schedule Seminal fluid Sex Functioning Specimen Spermatogenesis Steroids Study Subject Symptoms Testing Testosterone Urinalysis Urine Visit Writing contraceptive efficacy demographics diaries eligible participant male man meetings men screening sperm cell

项目摘要

A safe and reversible contraceptive method for men is androgen plus progestin or Nestoronegel and Testosterone gel applied transdermally. This combination supresses spermatogenesis. There are very few contraceptive options available to men. Studies indicate that men would use a safe and reversible method of contraception if one were available to them. One promising regimen involves a method of delivering androgen plus progestin in order to suppress sperm production. Previous studies demonstrated the gonadotropin and sperm suppressing capability of Nestorone® gel and testosterone gel preparations applied transdermally. For the present study, both steroids have been combined into a single gel formulation. This Task Order is for the conduct of a Phase lb clinical trial to test whether the combined Nestorone® and Testosterone gel product maintains similar pharmacokinetic and pharmacodynamic properties as were found for the two steroids in separate gel formulations. If a combination Nestorone® and T gel regimen is effective at gonadotropin suppression, the NICHD may elect to conduct a larger study to evaluate the product using contraceptive efficacy as the primary endpoint.

对男性来说，一种安全和可逆的避孕方法是雄激素加孕激素或雀巢和睾丸素凝胶经皮使用。这种结合抑制了精子的发生。男性可以选择的避孕方法很少。研究表明，男性会使用安全和可逆的避孕方法，如果他们可以使用的话。一件有希望的事该方案涉及一种传递雄激素和孕激素的方法，以抑制精子制作。以前的研究证明了促性腺激素和精子抑制能力 Nestorone®凝胶和睾酮凝胶制剂经皮使用。在本研究中，这两种类固醇已经被组合成单一的凝胶配方。此任务顺序适用于进行1b期临床试验，以测试Nestorone®和睾酮联合凝胶产品的药代动力学和药效学性质与已发现的这两种类固醇在不同的凝胶配方中。如果Nestorone®和T Gel联合治疗方案在抑制促性腺激素方面，NICHD可能会选择进行一项更大规模的研究以避孕效果为主要终点对产品进行评估。