Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00490555
Status:
COMPLETED
Last Update Posted:
2013-11-15
First Post:
2007-06-20
Brief Title:
PROS-1-Male Hormonal Contraceptive Regimens on Prostate Tissue
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
The Effect of Male Hormonal Contraceptive Regimens on Prostate Tissue In Normal Men
Status:
COMPLETED
Status Verified Date:
2013-09
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:
PROS-1
Brief Summary:
The investigators propose to examine the in vivo responses to hormonal manipulation at the molecular level directly in the tissue of interest prostate As in the investigators previous pilot study the investigators will use the novel approach of procuring tissue specimens from normal healthy men who might be chose to use a male hormonal contraceptive regimen were it available The investigators will employ state of the art techniques such as laser capture microdissection LCM and cDNA microarrays to determine the tissue-specific consequences of male hormonal contraceptive regimens on the prostate The results will help guide the design safety monitoring and selection of male hormonal contraceptive agents and provide valuable insights into prostate human prostate biology
The investigators will test the hypothesis that exogenous T administration that results in increased circulating T and dihydrotestosterone DHT levels will increase intraprostatic concentrations of T and its metabolite DHT
The investigators will test the hypothesis that the addition of a potent 5α-reductase inhibitor dutasteride or the progestin Depomedoxyprogesterone IM DMPA to T administration in young and middle aged men will decrease intraprostatic DHT and increase intraprostatic T concentrations compared to T alone
The investigators will test the hypothesis that the addition of a 5α-reductase inhibitor dutasteride or the progestin IM DMPA to exogenous T by reducing intraprostatic DHT will decrease prostate epithelial proliferation assessed by Ki-67 labeling index Ki-67LI and increase apoptosis assessed by caspase-3 expression and decrease androgen-regulated protein expression such as prostate specific antigen PSA
The investigators will test the hypothesis that the addition of a 5α-reductase inhibitor or the progestin IM DMPA to exogenous T by modifying the intraprostatic hormonal milieu will alter prostate epithelial gene expression Specifically the investigators expect that the addition of the 5α-reductase inhibitor dutasteride or the progestin IM DMPA to exogenous T will result in decreased expression of androgen-regulated genes such as PSA
The investigators will test the hypothesis that exogenous T administration that results in increased circulating T and dihydrotestosterone DHT levels will increase intraprostatic concentrations of T and its metabolite DHT
The investigators will test the hypothesis that the addition of a potent 5α-reductase inhibitor dutasteride or the progestin Depomedoxyprogesterone IM DMPA to T administration in young and middle aged men will decrease intraprostatic DHT and increase intraprostatic T concentrations compared to T alone
The investigators will test the hypothesis that the addition of a 5α-reductase inhibitor dutasteride or the progestin IM DMPA to exogenous T by reducing intraprostatic DHT will decrease prostate epithelial proliferation assessed by Ki-67 labeling index Ki-67LI and increase apoptosis assessed by caspase-3 expression and decrease androgen-regulated protein expression such as prostate specific antigen PSA
The investigators will test the hypothesis that the addition of a 5α-reductase inhibitor or the progestin IM DMPA to exogenous T by modifying the intraprostatic hormonal milieu will alter prostate epithelial gene expression Specifically the investigators expect that the addition of the 5α-reductase inhibitor dutasteride or the progestin IM DMPA to exogenous T will result in decreased expression of androgen-regulated genes such as PSA
Detailed Description:
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 contraception
We will be administering three drugs in this study Testim testosterone T gel dutasteride which affects testosterone break down and Depomedoxyprogesterone DMPA a progestin 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 DMPA 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 Prolonged 1 month low levels of LH and FSH cause decreased sperm production in normal men However men may experience some side effects from the low levels of testosterone caused by DMPA adding testosterone to DMPA eliminates these side effects while more effectively blocking LH and FSH release and sperm production This combination of drugs is a promising male contraceptive regimen However the effect of these drugs on the prostate is not known Some studies suggest that testosterone administration may promote prostate growth Dutasteride blocks the conversion of testosterone to dihydrotestosterone and is used to treat men with enlarged prostates Dutasteride shrinks the prostate It is possible that combining testosterone and dutasteride may be an effective part of a male hormonal contraceptive regime Therefore further studies examining the effect of testosterone DMPA and dutasteride on the prostate are needed
We will be administering three drugs in this study Testim testosterone T gel dutasteride which affects testosterone break down and Depomedoxyprogesterone DMPA a progestin 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 DMPA 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 Prolonged 1 month low levels of LH and FSH cause decreased sperm production in normal men However men may experience some side effects from the low levels of testosterone caused by DMPA adding testosterone to DMPA eliminates these side effects while more effectively blocking LH and FSH release and sperm production This combination of drugs is a promising male contraceptive regimen However the effect of these drugs on the prostate is not known Some studies suggest that testosterone administration may promote prostate growth Dutasteride blocks the conversion of testosterone to dihydrotestosterone and is used to treat men with enlarged prostates Dutasteride shrinks the prostate It is possible that combining testosterone and dutasteride may be an effective part of a male hormonal contraceptive regime Therefore further studies examining the effect of testosterone DMPA and dutasteride 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 |
|---|---|---|---|
| 06-4795-A 01 | OTHER | University of Washington IRB old application number | None |
| RFA-HD-06-014 | None | None | None |