Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161486
Status:
COMPLETED
Last Update Posted:
2008-09-19
First Post:
2005-09-08
Brief Title:
The Effects of Testosterone on Prostate Tissue ACYP-1
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
The Effects of Testosterone on Prostate Tissue in Normal Men ACYP-1
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:
ACYP-1
Brief Summary:
The purpose of this research study is to understand the effects of testosterone on the prostate This knowledge will be used to help in the development of a safe male hormonal contraceptive and may impact the development of androgen replacement therapy in older men
Detailed Description:
We will be administering two drugs Testim testosterone gel and Acyline Acyline is an experimental drug We want to see their effects on levels of hormones in the blood and prostate In addition we will be examining the effects of these drugs on the expression of genes within the prostate
Acyline suppresses LH and FSH which are hormones made by the pituitary gland thus blocking the signal from the brain that causes the testes to make testosterone Therefore Acyline blocks testosterone production In preliminary studies a single injection of Acyline reversibly lowered the FSH LH and testosterone levels in the blood for approximately 15 days Prolonged low levels of LH and FSH cause suppression of sperm production in normal men However men may experience some side effects from the low levels of testosterone caused by acyline thus exogenous testosterone is required to sustain normal male androgen and organ effects without suppressing spermatogenesis This combination of drugs is a promising male contraceptive regimen In addition millions of older men are using testosterone replacement to treat male andropause low level testosterone associated with aging However the effect of testosterone on the prostate is unknown Studies examining the effect of testosterone on the prostate are needed
Acyline suppresses LH and FSH which are hormones made by the pituitary gland thus blocking the signal from the brain that causes the testes to make testosterone Therefore Acyline blocks testosterone production In preliminary studies a single injection of Acyline reversibly lowered the FSH LH and testosterone levels in the blood for approximately 15 days Prolonged low levels of LH and FSH cause suppression of sperm production in normal men However men may experience some side effects from the low levels of testosterone caused by acyline thus exogenous testosterone is required to sustain normal male androgen and organ effects without suppressing spermatogenesis This combination of drugs is a promising male contraceptive regimen In addition millions of older men are using testosterone replacement to treat male andropause low level testosterone associated with aging However the effect of testosterone on the prostate is unknown Studies examining the effect of testosterone on the prostate are needed
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 |
|---|---|---|---|
| U 54 HD42454 | None | None | None |