Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future.

We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption.

Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); GlaxoSmithKline; National Institutes of Health (NIH)
• Treatments: Androgens; Dutasteride; Leuprolide; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Male 18-50 yrs old

• In good general health based on normal screening evaluation (consisting of medical history, physical exam, normal serum chemistry, hematology, and baseline hormone levels)

Exclusion Criteria:

• Poor general health, with abnormal blood results at screening

• A known history of alcohol or drug abuse

• Participation in a long-term male contraceptive study within three months of screening