CCTN - MALE SITES - CLINICAL EVALUATION OF NESTORONE GEL AND TESTOSTERONE

这项拟议的研究将在男性身上进行，以评估在希望避免怀孕并愿意将该方法作为主要节育方法的夫妇中，经皮使用的雀巢龙凝胶和睾酮凝胶的安全性和避孕效果。 除了睾酮(T)凝胶(雄激素)外，雌激素凝胶(孕激素)和睾酮(T)凝胶(雄激素)都被证明可以抑制促性腺激素和精子的产生。这些研究的初步结果表明，需要8毫克的雀巢龙凝胶才能充分抑制促性腺激素，达到抑制精子生成的水平。男性可以选择的避孕方法很少。研究表明，如果有安全和可逆的避孕方法，男性会使用。一种有希望的疗法涉及一种传递雄激素和孕激素的方法，以抑制精子产生。这项研究的目的是进行一项临床试验，以测试两种经皮应用的雀巢和睾酮对愿意将这种方法作为主要避孕方法的夫妇是否有效。这项拟议的研究将在男性身上进行，以评估雀巢龙凝胶和睾酮凝胶的安全性和避孕效果。

The proposed study will be conducted in men in order to evaluate the safety and contraceptive efficacy of Nestorone gel and testosterone gel, both applied transdermally, in couples who wish to avoid pregnancy and are willing to use the method as their primary method of birth control. Nestorone gel (progestogen) in addition to testosterone (T) gel (androgen), both applied transdermally, has been shown to suppress gonadotropins and sperm production. Preliminary results from these studies indicate that a dose of 8 mg of Nestorone gel is required in order to suppress gonadotropins sufficiently to a level that inhibits 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 progestogen in order to suppress sperm production. The goal of this study is to conduct a clinical trial to test whether Nestorone and testosterone, both applied transdermally, will be effective for contraception in couples who are willing to use the method as their primary method of contraception. The proposed study will be conducted in men in order to evaluate the safety and contraceptive efficacy of Nestorone gel and testosterone gel.