Short-term Effects of Aromatase Inhibition in Obese Men

Obesity Clinical Trial

Official title: Short-term Effects of Aromatase Inhibition in Obese Men

Status Completed

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadotrophic Hypogonadism
• Obesity

• NCT number: NCT00138710
• Study type: Interventional
• Source: Rijnstate Hospital
• Status: Completed
• Phase: Phase 3
• Start date: August 2005
• Completion date: January 2010