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

旨在调查潜力的第一阶段随机、开放标签交叉研究

• 批准号: 7952256
• 负责人: RONALD Sherwin SWERDLOFF
• 金额: $ 35.83万
• 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: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952256
• 关键词: Blood; Blood Chemical Analysis; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Couples; Cream; Cross-Over Studies; Electrocardiogram; Female; Funding; Grant; Hematology; Hormones; Informed Consent; Institution; Laboratories; Medical History; Phase; Physical Examination; Pregnancy Tests; Process; Prostate; Randomized; Research; Research Personnel; Resources; Safety; Screening procedure; Serum; Skin; Source; Stream; Testing; Testosterone; Transference; United States National Institutes of Health; Visit; Woman; digital; male; men; menthyl 3-(2-pyridylsulfinyl)acrylate; open label; rectal

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).

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这是一项I期，随机，开放标签的跨界研究，可研究睾丸激素霜（ARD-0403）的潜在转移。 预计多达15对健康的夫妇将进入这项研究。 这种睾丸激素霜不会对缺乏睾丸激素的男性进行测试。 这项研究的主要原因是查看在皮肤直接皮肤接触时，将睾丸激素霜应用于男性受试者的皮肤时是否会转移给女性伴侣。睾丸激素可以转移到雌性并被女性皮肤吸收，如果这样，将进入血液。 在参与研究之前，潜在的受试者（男女）将进行筛查，以确定他们很健康。这次访问将包括知情同意过程，病史，体格检查（包括男性的数字直肠检查以检查前列腺大小），心电图（ECG）（ECG），安全实验室评估（由男性PSA组成，女性妊娠试验，血液学，血液学，血液化学筛查测试和血清激素水平）。