Short-term Effects of Aromatase Inhibition in Obese Men
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.
Drug: Letrozole (Femara)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Short-term Effects of Aromatase Inhibition in Obese Men|
- 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)
- Lipid profile
- Blood counts
- Bone markers
- Liver enzymes
|Study Start Date:||August 2005|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00138710
|Arnhem, Netherlands, 6815 AM|
|Principal Investigator:||Hans de Boer, MD PhD||Rijnstate Hospital, Arnhem, the Netherlands|