Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00490022
Status:
COMPLETED
Last Update Posted:
2011-06-27
First Post:
2007-06-20
Brief Title:
Effect of Dihydrotestosterone DHT on Prostate Tissue Short Title DHT-3
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
The Effect of Dihydrotestosterone DHT on Prostate Tissue Androgen Concentrations and Inflammation in Normal Men
Status:
COMPLETED
Status Verified Date:
2011-06
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:
DHT-3
Brief Summary:
The purpose of this research study is to understand the effects of a male hormone normally made in the body called Dihydrotestosterone DHT on the prostate gland that is located under the bladder The knowledge gained from this study may be used to help in the future to develop a safe male hormonal contraceptive to prevent pregnancy in the safe treatment of low male hormone levels in men and in the treatment and prevention of diseases of the prostate
The investigators will be giving DHT in a gel form to be applied to the skin or a placebo gel with no active drug in it The investigators want to see the effects of DHT on levels of hormones in the blood and in the prostate gland itself In addition the investigators will be studying the effects of DHT on the cells and genes expressed within the prostate
The effect of DHT on the prostate is not known Some studies suggest blocking production of DHT in the prostate helps growth of the gland with aging a condition known as benign prostatic hyperplasia or BPH for short and may prevent prostate cancer On the other hand DHT administration may shrink the prostate suggesting it may be beneficial for some men Therefore further studies looking at the effect of DHT on the prostate are needed
The investigators will be giving DHT in a gel form to be applied to the skin or a placebo gel with no active drug in it The investigators want to see the effects of DHT on levels of hormones in the blood and in the prostate gland itself In addition the investigators will be studying the effects of DHT on the cells and genes expressed within the prostate
The effect of DHT on the prostate is not known Some studies suggest blocking production of DHT in the prostate helps growth of the gland with aging a condition known as benign prostatic hyperplasia or BPH for short and may prevent prostate cancer On the other hand DHT administration may shrink the prostate suggesting it may be beneficial for some men Therefore further studies looking at the effect of DHT on the prostate are needed
Detailed Description:
In this study we will examine the in vivo effects of DHT supplementation on the prostate and serum inflammatory markers at the molecular level We hypothesize that increases in serum DHT will not increase intraprostatic DHT or prostate epithelial proliferation and will be associated with decreases in markers of systemic inflammation Normal healthy male study volunteers will be treated with either placebo gel Group 1 or DHT gel Group 2 for one month Serum hormonal and inflammatory measurements will be assessed before during and after treatment and the relationship between hormones and inflammatory markers associated with cardiovascular risk will be determined Prostate biopsies will be taken after one month of treatment Prostate tissue will be analyzed for changes in intraprostatic hormone levels as well as gene expression following treatment
SPECIFIC AIMS
1 To determine the effect of increases in serum DHT without concomitant increases in serum T or estrogen on intraprostatic androgen levels
2 To determine the effect of increases in serum DHT without concomitant increases in serum T or estrogen on prostate epithelial gene expression
3 To determine the effect of increases in serum DHT without concomitant increases in serum T or estrogen on serum lipids and inflammatory markers including C-Reactive Protein CRP Tumor necrosis factor-alpha TNFα Interleukin-6 IL-6 adiponectin plasminogen activator inhibitor PAI-I and leptin
We will test the hypothesis in normal men rather than hypogonadal men as a proof of principle investigation A normal hypothalamic-pituitary-testicular axis and regulation circulating T and DHT levels and intraprostatic androgen concentrations in healthy normal men will permit optimal testing of the hypothesis Exogenous DHT administration in normal men is expected to suppress endogenous gonadotropin and testosterone secretion compared to more variable effects in hypogonadal men that depend on the degree of hypogonadism in these men and whether they have primary testicular or secondary hypothalamic-pituitary hypogonadism Furthermore intraprostatic T and DHT concentrations and 5 alpha-reductase activity that is androgen-dependent is expected to be more variable in hypogonadal men depending on the degree of androgen deficiency and circulating T and DHT levels If results in normal men support the hypothesis subsequent studies could be performed in hypogonadal men Because of the larger variability in circulating and probably intraprostatic androgen concentrations in hypogonadal men these studies will require much larger numbers of subjects
SPECIFIC AIMS
1 To determine the effect of increases in serum DHT without concomitant increases in serum T or estrogen on intraprostatic androgen levels
2 To determine the effect of increases in serum DHT without concomitant increases in serum T or estrogen on prostate epithelial gene expression
3 To determine the effect of increases in serum DHT without concomitant increases in serum T or estrogen on serum lipids and inflammatory markers including C-Reactive Protein CRP Tumor necrosis factor-alpha TNFα Interleukin-6 IL-6 adiponectin plasminogen activator inhibitor PAI-I and leptin
We will test the hypothesis in normal men rather than hypogonadal men as a proof of principle investigation A normal hypothalamic-pituitary-testicular axis and regulation circulating T and DHT levels and intraprostatic androgen concentrations in healthy normal men will permit optimal testing of the hypothesis Exogenous DHT administration in normal men is expected to suppress endogenous gonadotropin and testosterone secretion compared to more variable effects in hypogonadal men that depend on the degree of hypogonadism in these men and whether they have primary testicular or secondary hypothalamic-pituitary hypogonadism Furthermore intraprostatic T and DHT concentrations and 5 alpha-reductase activity that is androgen-dependent is expected to be more variable in hypogonadal men depending on the degree of androgen deficiency and circulating T and DHT levels If results in normal men support the hypothesis subsequent studies could be performed in hypogonadal men Because of the larger variability in circulating and probably intraprostatic androgen concentrations in hypogonadal men these studies will require much larger numbers of subjects
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 |
|---|---|---|---|
| 1K23AG027238-01A1 | NIH | None | httpsreporternihgovquickSearch1K23AG027238-01A1 |