ORAL T-6: Oral Androgens in Man-6

Oral Androgens in Man-6: Pharmacokinetics of Slow and Fast Release, External Matrix Oral Testosterone Formulations in Normal Men With Experimental Hypogonadism

We propose a study to determine the single-dose pharmacokinetics of these two novel formulations of testosterone in normal men with experimentally induced hypogonadism.

This is an 2-3 month open-label, two week pharmacokinetic study of two novel formulations of oral testosterone (T), in normal men whose endogenous T production has been temporarily suppressed by the administration of the potent GnRH antagonist Acyline. We will be determining the relative pharmacokinetics of six different oral formulations of T in both rapid and slow release compared to the immediate release preparation studied previously by our group.

Inclusion Criteria:

• males between 18 to 50 years of age in good general health based on normal screening evaluation
• must agree not to participate in another research drug study during participation
• must agree to not donate blood during the study
• must be willing to comply with the study protocol and procedures
• must agree to use an acceptable form of contraception
• agrees to not take medications other than the study drugs for the duration of the study

Exclusion Criteria:

• Subject in poor health, determined by medical history physical and lab results
• a known history or current use of alcohol, drug or steroid abuse and/or use of more than 3 alcohol beverages per day
• Participation in a long-term contraceptive study within the past two months
• History of bleeding disorders or current use of anti-coagulants
• History of sleep apnea and/or major psychiatric disorders