Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161421
Status:
COMPLETED
Last Update Posted:
2008-09-19
First Post:
2005-09-08
Brief Title:
Oral Androgens in Man-3 ORAL T-3 Pharmacokinetics of Oral Testosterone
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Oral Androgens in Man-3 Pharmacokinetics of Oral Testosterone With Concomitant Inhibition of 5α-Reductase by Dutasteride Short Title ORAL T-3
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
The drug Lupron will temporarily turn off the bodys production of testosterone after two weeks At that point we will administer testosterone by mouth on six days in the next two weeks to see how much is absorbed and present in the bloodstream after administration The day Lupron is given and for 24 days after that subjects will take the second medication Dutasteride which alters testosterone breakdown in the body Fifteen days after the Lupron shot subjects will take the first formulation of testosterone by mouth and undergo blood draws to see how much of this testosterone makes it into the blood stream and how long it lasts The next dayDay 2 subjects will take a larger dose of testosterone and undergo blood draws On study day 3 subjects will again take the larger dose of testosterone this time with a meal and undergo blood draws During the 2nd week of the study subjects will repeat the testosterone doses with a 2nd formulation of testosterone The first two doses of testosterone each week will be taken on an empty stomach while the third will be taken with breakfast Please note that six study days 12389 and 10 will require repeated blood draws over a 12 hour period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GSK002590 | US NIH GrantContract | None | httpsreporternihgovquickSearchK23HD045386 |
| HD42454 | None | None | None |
| K23HD045386 | NIH | None | None |