Expired Study
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Seattle, Washington 98195


Purpose:

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


Study summary:

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.


Criteria:

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


NCT ID:

NCT00663793


Primary Contact:

Principal Investigator
John K Amory
University of Washington


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98195
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 18, 2018

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