Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138710
Status:
COMPLETED
Last Update Posted:
2010-10-22
First Post:
2005-08-29
Brief Title:
Short-term Effects of Aromatase Inhibition in Obese Men
Sponsor:
Rijnstate Hospital
Organization:
Rijnstate Hospital
Study Overview
Official Title:
Short-term Effects of Aromatase Inhibition in Obese Men
Status:
COMPLETED
Status Verified Date:
2010-10
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:
In this study 50 obese men with a hormonal imbalance will be treated with letrozole or placebo for six months in order to examine the effects on the hormonal balance and on weight loss The study will also address the side effects and psychological effects of letrozole as compared to placebo
Detailed Description:
The aim of the study is to establish the short-term efficacy and safety of aromatase inhibition in restoring and maintaining eugonadism in hypogonadotrophic hypogonadal men Secondary aim is to detect the short-term somatic and psychological effects
Study design Double blind randomized placebo-controlled trial
Treatment 26 weeks of either letrozole or placebo All patients will start on 1 tablet per week dose adjustments will be performed if serum testosterone or estradiol are outside the target range All men will be prescribed a mildly hypocaloric diet
Endpoints BMI body weight waist circumference body composition exercise capacity serum levels of several hormone markers glucose tolerance psychological characteristics
All patients will be measured 6 times during the study
Study design Double blind randomized placebo-controlled trial
Treatment 26 weeks of either letrozole or placebo All patients will start on 1 tablet per week dose adjustments will be performed if serum testosterone or estradiol are outside the target range All men will be prescribed a mildly hypocaloric diet
Endpoints BMI body weight waist circumference body composition exercise capacity serum levels of several hormone markers glucose tolerance psychological characteristics
All patients will be measured 6 times during the study
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