A PHASE III OPEN-LABEL STUDY OF THE EFFICACY AND SAFETY OF ARD-0403

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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 III, open-label, dose-titration, multi-center study. Titration is defined as the process of gradually adjusting the dose of a medication until the desired effect is achieved. Up to 150 testosterone deficient men are expected to enter this study. Each of them will receive 28 daily applications of 2.25g ARD-0403. After 28 days of treatment, if testosterone levels are not within the reference 300- 700 ng/dL), the dose of ARD-0403 will be titrated, if serum testosterone levels are below 300 ng/dl, the dose will be increased by 2.25g to 4.5g and if the level is above 700 ng/dl, the dose will be decreased to 1.5 g. Further dose titrations may be made prior to patients entering a 12 week maintenance phase. Prior to participation in the study, potential subjects will undergo an "inclusion phase" to determine whether they are eligible for the study. This phase will include the informed consent process, washout of current androgen treatment (if applicable), physical examination (including a digital rectal exam to check prostate size), an electrocardiogram (ECG), safety laboratory assessments (consisting of PSA, hematology, and serum hormone levels). Subjects need to have documented serum total testosterone levels <250ng/dL on at least two occasions prior to enrolling into the study. Safety of the study drug will be assessed by evaluating the collected safety data of adverse events, serious adverse events (SAEs), ECG, vital signs, application site reactions and clinical laboratory parameters (biochemistry and hematology).