CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - MALE

CCTN - 避孕临床试验网络 - 男性

• 批准号: 8937516
• 负责人: UNKNOWN UNKNOWN
• 金额: $ 36.26万
• 依托单位: UNIVERSITY OF WASHINGTON
• 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 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8937516
• 关键词: Androgens; Clinical Trials; Clinical Trials Network; Contraceptive Agents; Contraceptive methods; Drug Formulations; Drug Kinetics; Gel; Gonadotropins; Methods; National Institute of Child Health and Human Development; Nestorone; Pharmacodynamics; Phase; Preparation; Production; Progestins; Property; Regimen; Safety; Steroids; Testing; Testosterone; contraceptive efficacy; male; men; sperm cell

SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS AND GONADOTROPIC SUPPRESSIVE EFFICACY OF COMBINATION NESTORONE AND TESTTOSTERONE GEL IN MEN. PREPARATIONS ARE APPLIED TRANSDERMALLY Conduct a Phase Ib clinical trial to determine if the combination of drug formulation will efficiently suppress gonadotropin production. SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS AND GONADOTROPIN SUPPRESSIVE EFFICACY OF COMBINED NESTORONE® AND TESTOSTERONE GEL IN MEN” 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 Ib 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.

奈斯托酮和睾酮凝胶在男性中的安全性、药代动力学、药效学和促性腺激素抑制效果。制剂经皮施用