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

CCTN - 男性网站 - 雀酮凝胶和睾酮的临床评估

• 批准号: 10618766
• 负责人: CHRISTINA WANG
• 金额: $ 232.17万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-15 至 2023-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10618766
• 关键词: Androgens; Clinical Trials; Contraceptive Agents; Contraceptive methods; Couples; Dose; Gel; Goals; Gonadotropins; Methods; Nestorone; Pregnancy; Production; Progestins; Regimen; Safety; Spermatogenesis; Testing; Testosterone; birth control; clinical research site; contraceptive efficacy; efficacy clinical trial; male; men; research clinical testing; sperm cell

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.

拟定的研究将在男性中进行，以评价Nestorone凝胶和睾酮凝胶的安全性和避孕效果，这两种凝胶都是经皮应用的，适用于希望避免怀孕并愿意将该方法作为其主要避孕方法的夫妇。 除了睾酮（T）凝胶（雄激素）外，经皮应用的Nestorone凝胶（孕激素）已被证明可抑制促性腺激素和精子生成。 这些研究的初步结果表明，需要8 mg剂量的Nestorone凝胶才能将促性腺激素充分抑制到抑制精子发生的水平。 男性可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，男性会使用这种方法。 一个有希望的方案涉及一种方法，提供雄激素加孕激素，以抑制精子的产生。 本研究的目的是进行一项临床试验，以测试经皮应用的Nestorone和睾酮是否对愿意使用该方法作为主要避孕方法的夫妇有效。 拟定的研究将在男性中进行，以评价Nestorone凝胶和睾酮凝胶的安全性和避孕效果。