CCTN- CONTRACEPTIVE CLINICAL TRIALS NETWORK - MALE SITES - NESTORONE AND TESTOSTERONE GEL

CCTN- 避孕临床试验网络 - 男性站点 - 雀酮和睾酮凝胶

• 批准号: 9145821
• 负责人: WILLIAM BREMNER
• 金额: $ 236.77万
• 依托单位: UNIVERSITY OF WASHINGTON
• 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 2019-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9145821
• 关键词: Androgens; Biological Assay; Child; Child health care; Clinical; Clinical Practice Guideline; Clinical Trials; Clinical Trials Network; Conduct Clinical Trials; Contraceptive Agents; Contraceptive methods; Contractor; Contracts; Couples; Data Analyses; Development; Dose; Enrollment; Gel; Goals; Gonadotropins; Good Clinical Practice; Government; Human Development; Institutes; International; Male Contraceptive Agents; Measures; Methods; Mission; Monitor; National Institute of Child Health and Human Development; Nestorone; Phase; Pregnancy; Production; Progestins; Protocols documentation; Records; Recovery; Regimen; Regulation; Resolution; Safety; Site; Spermatogenesis; Testing; Testosterone; Time; Vasectomy; Woman; birth control; condoms; contraceptive efficacy; follow-up; hormonal contraception; male; men; protocol development; sperm cell; symposium

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 the Task Order is to conduct a clinical trial to test whether Nestorone® gel (progestogen) and testosterone (T) gel (androgen), both applied transdermally, will be effective for contraception in couples who are willing to use the method as their primary method of contraception. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has a mission to develop safe and effective contraceptives for both men and women. Many women cannot use hormonal contraception and rely on their male partner to protect them from pregnancy. Current methods available for men are limited to vasectomy and condoms. Development of effective male contraceptive regimens remains a challenge for the field. In a clinical trial conducted in the NICHD Contraceptive Clinical Trials Network (CCTN), Nestorone® gel (progestogen) and testosterone (T) gel (androgen), both applied transdermally, was effective in suppressing gonadotropins and inhibiting spermatogenesis. The proposed study will be conducted in men in order to evaluate the safety and contraceptive efficacy of this regimen in couples who wish to avoid pregnancy and are willing to use the method as their primary method of birth control.

Nestorone®凝胶（孕激素）和睾酮（T）凝胶（雄激素），均应用于 经皮给药已显示抑制促性腺激素和精子产生。初步 这些研究的结果表明，需要8 mg Nestorone®凝胶的剂量， 将促性腺激素抑制到足以抑制精子发生的水平。很少有 为男性提供避孕选择。研究表明，男性会使用安全且可逆的 避孕方法，如果有一种方法可以使用。一个有希望的方案涉及一个 递送雄激素加孕激素以抑制精子产生的方法。目标 任务指令的第一步是进行临床试验，以测试Nestorone®凝胶（孕激素）和 睾酮（T）凝胶（雄激素），都是经皮应用，将有效避孕， 愿意使用该方法作为主要避孕方法的夫妇。 尤妮斯·肯尼迪·施莱佛国家儿童健康和人类发展研究所 （NICHD）的使命是为男女开发安全有效的避孕药具。 许多妇女不能使用激素避孕药，只能依靠男性伴侣来保护她们。 因为怀孕目前可用于男性的方法仅限于输精管结扎术和避孕套。 制定有效的男性避孕方案仍然是该领域的一项挑战。中 在NICHD避孕临床试验网络（CCTN）中进行的临床试验， Nestorone®凝胶（孕激素）和睾酮（T）凝胶（雄激素），均经皮应用， 有效抑制促性腺激素和抑制精子发生。拟定研究 将在男性中进行，以评价这种药物的安全性和避孕效果。 对于那些希望避免怀孕并愿意使用这种方法作为其治疗方法的夫妇， 避孕的主要方法。