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

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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).