This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor 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).The subjects will receive testosterone replacement during the days they are taking the testosterone but during the wash-out period before they participate in the study, the subjects may experience decreased sexual function and energy. The known potential adverse effects of testosterone such as acne, weight gain, oiliness of skin will be monitored. Because of the short duration, we do not expect to see any changes in red cell indices, serum PSA levels (marker of prostate disease) or lipid profile. There is no direct benefits to the participants but the study may help to develop a transdermal testosterone preparation that may be easier to apply than the currently approved testosterone gels. The informed consent process will take place prior to any involvement of a subject ina research trial. Subjects will be fully informed of all associated procedures and their potential risks and benefits; and will have any questions addressed prior to voluntarily signing the informed consent for the study. The informed consent discussion will last until both the subject and the person obtaining consent feel confident that the trial has been satisfactorily described and the subject has a reasonable understanding of the consequences of their participation. Potential subjects will be given ample opportunity to read the informed consent document and consider whether or not they want to participate in the study. This study will be carried out in accordance with the Principles of International Conference on Harmonization (ICH) Good Clinical Practice (GCP) which build upon the ethical codes contained in the current version of the Declaration of Helsinki.
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