A MULTICENTER, RANDOMIZED COMPARATOR TRIAL OF THE SAFETY AND SPERM AND GONADOTRO

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 本研究的目的是测试Nestorone凝胶与Teastrone凝胶组合是否比单独使用睾酮（T）凝胶更好地抑制精子生成。这项研究的长期目标是开发新的男性避孕药，这些避孕药安全，有效，自我交付，易于使用，可逆且负担得起。目前，男子可用的避孕选择仅限于避孕套和输精管结扎术。本研究中使用的Tezogel已被FDA批准用于性腺功能减退的男性（血液睾酮水平低），并以AndroGel和Testogel的名称提供。Nestorone凝胶是一种新的雌激素衍生物。 这项研究将需要10至11个半月才能完成。在研究筛选前6个月内，不允许潜在受试者使用激素治疗。要求潜在受试者在研究期间使用批准的有效避孕方法，如避孕套。在筛选访视期间，将根据病史、体格检查（包括直肠指检）、血液（包括激素）和尿液实验室检查以及精子分析确定入选资格。受试者将在医生办公室的私人房间通过手淫收集精子样本。要求受试者在研究访视前2-5天内避免射精，此时将采集精子样本。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to test whether Nestorone gel in combination with Testosterone gel will be better in suppressing sperm production than testosterone (T) gel alone. This study is being done with a long-term goal to develop new male contraceptives that are safe, effective, self delivered, easy to use, reversible, and affordable. Currently, contraception options available to men are limited to condoms and vasectomy. Testosterone gel being used in this study has been approved by the FDA for the use in hypogonadal men (with low blood testosterone levels) and is available under names AndroGel¿¿ and Testogel¿¿. Nestorone gel is a new derivative of progestin (female hormone). The study will take 10 to 11 1/2 months to complete. Potential subjects will not be allowed to have used hormonal therapy in the 6 months preceding study screening. Potential subjects will be required to use an approved and effective method of contraception, such as condom, for the duration of the study. Eligibility will be determined during screening visits based on medical history, physical examination including digital rectal exam, laboratory tests done on blood (including hormones) and urine, and sperm analysis. Subjects will collect sperm samples by masturbation in a private room at the doctor s office. Subjects will be required to abstain from ejaculation for 2-5 days prior to study visits when sperm samples are to be collected.