Status:
COMPLETED
Short-term Effects of Aromatase Inhibition in Obese Men
Lead Sponsor:
Rijnstate Hospital
Conditions:
Hypogonadotrophic Hypogonadism
Obesity
Eligibility:
MALE
20-50 years
Phase:
PHASE3
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 wi...
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...
Eligibility Criteria
Inclusion
- BMI between 35 and 50
- Male sex
- Ages between 20 and 50
- Serum total testosterone under 10 nmol/l
- Serum luteinizing hormone (LH) under 9 mU/l
- Serum estradiol over 40 pmol/l
Exclusion
- Comorbidity
- Serum prostate-specific antigen (PSA) over 4.0 U/l
- Discontinuation of smoking less than six months ago
- Medication known to affect hormonal parameters
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00138710
Start Date
August 1 2005
End Date
January 1 2010
Last Update
October 22 2010
Active Locations (1)
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1
Rijnstate Hospital
Arnhem, Netherlands, 6815 AM