ORAL T-6: Oral Androgens in Man-6

Completed · Phase 1

Conditions studied: Contraception, Hypogonadism

In brief

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

Key facts

Study ID

NCT00663793

Run by

University of Washington

People needed

16

Starts

2008-10-01

Expected to finish

2009-06-01

Last updated by the study team

2011-01-24

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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