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).

这个子项目是许多研究子项目中的一个 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来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项I期、随机、开放标签、交叉研究，旨在研究睾酮乳膏（ARD-0403）从男性向女性伴侣的潜在转移。 预计多达15对正常健康夫妇将进入本研究。 这种睾酮霜不会对缺乏睾酮的男性进行测试。 这项研究的主要原因是，当睾酮霜应用于男性受试者的皮肤时，如果有直接的皮肤接触，它是否会转移到女性伴侣身上。睾丸激素可能会转移到女性和吸收的妇女的皮肤，如果是这样，有多少将进入血液。 在参与研究之前，潜在受试者（男性和女性）将接受筛选访视，以确定他们是否健康。该访视将包括知情同意过程、病史、体格检查（包括男性直肠指检以检查前列腺大小）、心电图（ECG）、安全性实验室评估（包括男性PSA、女性妊娠试验、血液学、血生化筛选试验和血清激素水平）。