ORAL ANDROGENS IN MAN-4: GONADOTROPIN SUPPRESSION

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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 recently completed work has demonstrated that oral testosterone (T) therapy with testosterone enanthate in oil combined with the 5-alpha reductase inhibitor dutasteride can result in elevated serum T levels that would allow for the use of oral T in a male contraceptive regimen. Specifically, a 400 mg dose of testosterone enanthate (TE) in oil provides elevations of testosterone to the normal range for up to ten hours, and an 800 mg dose of oral testosterone provides initially supraphysiological serum testosterone levels than remain above the lower limit of the normal range for 12+ hours. Moreover, our work has demonstrated that the co-administration of the 5-alpha 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 a male hormonal contraceptive. We wish to expand our knowledge about the pharmacodynamic effects of oral TE administration to see if oral TE could have potential as a male hormonal contraceptive. Therefore, in this study, we wish to extend the dosing period of oral TE in oil to 4 weeks to determine if oral TE can suppress the secretion of LH and FSH from the pituitary, which is the main mechanism by which male hormonal contraceptives function. The primary biological end point in this trial will be suppression in serum LH and FSH while monitoring for any adverse changes in laboratory tests or general health.