CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - MALE

男性使用复方睾酮凝胶的安全性、药代动力学、药理学和促性腺激素抑制疗效。豁免适用于透皮 进行Ib期临床试验，以确定药物制剂的组合是否能有效抑制促性腺激素的产生。 安全性、药代动力学、药理学和促性腺激素 NESTORONE®和睾酮凝胶联合应用对男性的抑制效果” 男性可选择的避孕方法很少。研究表明，男性会使用安全的， 可逆的避孕方法，如果一个是提供给他们。一个有希望的方案涉及一个 递送雄激素加孕酮以抑制精子产生的方法。以前的研究 证明了Nestorone®凝胶和睾酮凝胶的促性腺激素和精子抑制能力 经皮给药的制剂。对于目前的研究，这两种类固醇已合并成一个单一的， 凝胶制剂。本任务指令用于开展Ib期临床试验，以测试 组合的Nestorone®和Teastolone凝胶产品保持相似的药代动力学， 这两种类固醇在不同的凝胶制剂中具有相同的药效学特性。如果 联合Nestorone®和T凝胶方案对促性腺激素抑制有效，NICHD可能 选择进行一项更大规模的研究，以避孕效果作为主要评价产品 终点。

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.