ORAL ANDROGENS IN MAN-3: PK OF ORAL TESTOSTERONE BY ALPHA5-DUTASTERIDE

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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. Our work has demonstrated that oral testosterone (T) therapy can result in serum T levels that would allow for the use of oral T in the treatment of T deficiency. Moreover, our work has demonstrated that the co-administration of the 5a reductase inhibitor dutasteride with oral T increases serum T levels while decreasing serum DHT levels-an effect that may improve the long-term safety profile of androgen therapy. One impediment to oral testosterone is the requirement that the testosterone be administered in oil. The objective of this current proposal is to: 1) ascertain if one of two newer formulations of oral testosterone (T) with concomitant 5a reduction by dutasteride can result in serum T levels that may allow for the use of oral T in the treatment of men with T deficiency. In this study, we will be administering oral T to 16 normal men whose own production of T has been temporarily shut down by the administration of the gonadotropin-releasing hormone agonist Lupron. Two weeks after Lupron administration, subjects will receive a series of doses of two different formulations or oral T. They will also be taking dutasteride. We wish to determine if the co-administration of oral T and dutasteride can result in a usable form of T therapy that allows for the benefits of T without the drawbacks of DHT. The primary biological end points in this trial will be elevations in serum T while monitoring for any adverse changes in liver function or general health.