Short-term Effects of Aromatase Inhibition in Obese Men
|Hypogonadotrophic Hypogonadism Obesity||Drug: Letrozole (Femara)||Phase 3|
|Study Design:||Allocation: Randomized
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|