CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - MALE

男性联合应用雌酮和睾酮凝胶的安全性、药动学、药效学和促性腺激素抑制效果。制剂是经皮使用的 进行Ib期临床试验，以确定药物组合是否将有效地抑制促性腺激素的产生。 安全性、药动学、药效学和促性腺激素 联合应用睾酮和睾酮凝胶对男性的抑制作用“ 男性可以选择的避孕方法很少。研究表明，男性会使用保险箱和 可逆的避孕方法，如果他们可以使用的话。一种有希望的养生法包括 注射雄激素加孕激素以抑制精子产生的方法。以前的研究 展示了Nestorone®凝胶和睾酮凝胶的促性腺激素和精子抑制能力 制剂是经皮使用的。在目前的研究中，这两种类固醇已经被结合成一个单一的 凝胶配方。本任务单用于进行Ib期临床试验，以测试 Nestorone®和睾酮联合凝胶产品保持相似的药代动力学和 在不同的凝胶制剂中发现了这两种类固醇的药效学特性。如果一个 Nestorone®联合T Gel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，以避孕效果为主要指标来评估该产品 终结点。

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.