Short-term Effects of Aromatase Inhibition in Obese Men

Phase 3

Completed

• Conditions: Hypogonadotrophic Hypogonadism; Obesity

• Registration Number: NCT00138710
• Lead Sponsor: Rijnstate Hospital

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 Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-29
• Study First Posted: 2005-08-30
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-21
• Last Update Posted: 2010-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Lipid profile
Blood counts
Bone markers
Liver enzymes

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands