Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone
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.
Timeline
- Start
- 2005-03
- Primary completion
- 2006-07
- Completion
- 2006-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Testosterone | Small molecule | 200 mg | Oral |
| Subject | Testosterone | Small molecule | 400 mg | Oral |
| Background | Dutasteride | Small molecule | 0.5 mg | — |
| Background | Leuprolide | Other / unclassified | 7.5 mg | Intramuscular |