Short-term Effects of Aromatase Inhibition in Obese Men

Study Overview
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Brief Summary
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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
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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.

Official Title
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Short-term Effects of Aromatase Inhibition in Obese Men

Conditions
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Hypogonadotrophic Hypogonadism, Obesity

Intervention / Treatment
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* Drug: Letrozole (Femara)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Letrozole (Femara)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  |  | 
| Body mass index (BMI) |  |  | 
| Waist circumference |  |  | 
| Body composition |  |  | 
| Exercise capacity |  |  | 
| Serum levels of hormones |  |  | 
| Glucose tolerance |  |  | 
| Reported side effects |  |  | 
| Psychological characteristics (Symptom Checklist, intelligence quotient [IQ] NPV) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile |  |  | 
| Blood counts |  |  | 
| Bone markers |  |  | 
| Liver enzymes |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, Hypogonadotrophic hypogonadism, aromatase inhibition