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).

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