Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399165
Status:
COMPLETED
Last Update Posted:
2008-09-22
First Post:
2006-11-09
Brief Title:
Oral Androgens in Man-4 Short Title Oral T-4
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Oral Androgens in Man-4 Gonadotropin Suppression Medicated by Oral Testosterone Enanthate in Oil Plus Dutasteride Short Title Oral T-4
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 protocol was designed to address the hypothesis that oral testosterone enanthate plus dutasteride can suppress the secretion of LH and FSH after four weeks of administration In addition we will compare the gonadotropin suppression mediated by a dose of testosterone enanthate 400 mg twice daily that would be expected to maintain the serum testosterone in the normal range throughout the day with the same dose 800 mg once daily administered once daily This larger once-daily dose is expected to result in a higher peak and lower trough by the end of the dosing interval
Detailed Description:
This study will be carried out in a double-blinded fashion so neither the subject nor the investigator will be aware of treatment assignment during the study This protocol is designed to address the hypothesis that oral testosterone enanthate plus dutasteride can suppress the secretion of LH and FSH after four weeks of administration In addition we will compare the gonadotropin suppression mediated by a dose of testosterone enanthate 400 mg twice daily that would be expected to maintain the serum testosterone in the normal range throughout the day with the same dose 800 mg once daily administered once daily This larger once-daily dose is expected to result in a higher peak and lower trough by the end of the dosing interval Secondary endpoints in this study include the ability of oral testosterone enanthate plus dutasteride to maintain short-term androgen-mediated endpoints such as mood and sexual function over the 4-week treatment period as well as weekly measures of safety including blood counts PSA and liver and kidney function
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 |
|---|---|---|---|
| K23HD045386 | NIH | None | httpsreporternihgovquickSearchK23HD045386 |
| U54HD042454 | NIH | None | None |