Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070733
Status:
UNKNOWN
Last Update Posted:
2005-11-07
First Post:
2003-10-07
Brief Title:
The Effect of 5-Alpha Reductase on Testosterone in Men
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
The Role of 5-Alpha Reductase in Mediating Testosterone Actions
Status:
UNKNOWN
Status Verified Date:
2003-10
Last Known Status:
RECRUITING
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 enzyme 5-alpha reductase is present in small amounts in muscle and converts testosterone to dihydrotestosterone DHT Testosterone affects lean body tissue muscle size muscle strength and sexual function in men This study will evaluate how 5-alpha reductase influences the effects of testosterone in young healthy men
Detailed Description:
Testosterone the predominant circulating androgen in men serves as the active hormone in some target tissues however testosterone effects in other target organs require its conversion to two active metabolites estradiol 17-beta and DHT The role of 5-alpha reductase in mediating testosterones effects on muscle and sexual function remains unclear This study will determine whether 5-alpha reduction of testosterone to DHT is necessary for mediating effects on fat-free mass muscle size muscle strength and leg power in men The study will also evaluate the necessity of 5-alpha reductase for maintenance of androgen effects on sexual function sexual desire overall sexual activity nocturnal penile tumescence NPT response to visual erotic stimulus and penile rigidity in men
Participants in this study will be treated with a drug to suppress endogenous testosterone production Participants will then be randomly assigned to receive either testosterone and placebo or testosterone and the 5-alpha reductase inhibitor dutasteride Testosterone will be administered weekly dutasteride and placebo will both be administered daily Diet and exercise will be standardized across both groups Participants will be assessed at study entry and Week 20 Assessments will include measurements such as a DEXA scan MRI scan and muscle performance and sexual function tests Participants will also have blood tests for safety monitoring blood tests will include measures of hematocrit liver enzymes AST and ALT prostate specific antigen PSA and cholesterol
Participants in this study will be treated with a drug to suppress endogenous testosterone production Participants will then be randomly assigned to receive either testosterone and placebo or testosterone and the 5-alpha reductase inhibitor dutasteride Testosterone will be administered weekly dutasteride and placebo will both be administered daily Diet and exercise will be standardized across both groups Participants will be assessed at study entry and Week 20 Assessments will include measurements such as a DEXA scan MRI scan and muscle performance and sexual function tests Participants will also have blood tests for safety monitoring blood tests will include measures of hematocrit liver enzymes AST and ALT prostate specific antigen PSA and cholesterol
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