Status:
COMPLETED
ORAL T-6: Oral Androgens in Man-6
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Contraception
Hypogonadism
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
We propose a study to determine the single-dose pharmacokinetics of these two novel formulations of testosterone in normal men with experimentally induced hypogonadism.
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00663793
Start Date
October 1 2008
End Date
June 1 2009
Last Update
January 24 2011
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195