A PHASE III, RANDOMIZED, MULTI-CENTER, OPEN-LABEL, FOLLOW-ON STUDY FOR LONG T

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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, multi-centre, open-label, follow-on study for long-term safety and efficacy of testosterone cream, in testosterone deficient men completing study ARD-0403-004. All subjects completing the Phase III protocol ARD-0403-004 trial (Up to 150 men) will be invited to enter this extension study. About 20 of the subjects will be enrolled from our center. The objective of the study is to demonstrate the long term safety, tolerability and efficacy of treatment with ARD-0403, a testosterone cream, in men diagnosed to have testosterone deficiency. Each subject will undergo the informed consent process and inclusion phase for this study during their "End of Week 12" visit for protocol ARD-0403-004 (IRB#12843-01). 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. Information collected during the End of Week 12 visit of the main study will be carried over as baseline measures for the follow-on study.