A PHASE I, RANDOMIZED, OPEN-LABEL, CROSS-OVER STUDY TO INVESTIGATE POTENTIAL

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项I期随机开放交叉研究，旨在调查睾酮乳膏(ARD-0403)从男性伴侣到女性伴侣的潜在转移。 预计将有多达15对正常健康的夫妇参加这项研究。这种睾丸素乳膏不会在缺乏睾丸激素的男性身上进行测试。这项研究的主要原因是，当男性受试者的皮肤上涂抹睾丸素乳膏时，当皮肤与皮肤直接接触时，是否会转移到女性伴侣身上。睾丸激素可能会转移到女性身上，并被女性的皮肤吸收，如果是这样的话，有多少会进入血液循环。 在参与这项研究之前，潜在的受试者(男性和女性)将接受筛查访问，以确定他们是健康的。这次访问将包括知情同意过程、病史、体检(包括男性直肠指检以检查前列腺大小)、心电图(ECG)、安全实验室评估(包括男性PSA、女性怀孕测试、血液学、血液化学筛查测试和血清激素水平)。

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. This is a phase I, randomized, open-label, cross-over study to investigate potential transference of testosterone cream (ARD-0403) from male to female partner. Up to 15 normal healthy couples are expected to enter this study. This testosterone cream will not be tested on men who lack testosterone. The main reason for this study is to see if the testosterone cream when applied to the skin of a male subject will be transferred to the female partner when there is direct skin to skin contact. The testosterone may be transferred to the female and absorbed by the woman's skin and if so how much will enter the blood stream. Prior to participation in the study, potential subjects (men & women) will undergo a screening visit to establish that they are healthy. This visit will include the informed consent process, medical history, physical examination (including for men a digital rectal exam to check prostate size) an electrocardiogram (ECG), safety laboratory assessments (consisting of PSA for men, pregnancy test for women, hematology, blood chemistry screening tests, and serum hormone levels).