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

一种安全、可逆的男性避孕方法是雄激素加炔雌醇或Nestoronegel和Tehrogel透皮应用。这种结合抑制精子发生。 男性可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，如果他们可以得到。一个有希望 该方案包括一种方法，提供雄激素加孕酮，以抑制精子 生产以前的研究表明，促性腺激素和精子抑制能力， Nestorone®凝胶和睾酮凝胶制剂经皮应用。在本研究中， 这两种类固醇被组合成单一的凝胶制剂。本任务指令适用于 进行Ib期临床试验，以测试组合的Nestorone®和Tequilogel是否 本品保持了类似的药代动力学和药效学特性， 这两种类固醇在不同的凝胶制剂中。如果联合Nestorone®和T凝胶方案是 有效的促性腺激素抑制，NICHD可能会选择进行更大的研究， 使用避孕效果作为主要终点来评价产品。

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.