Short-term Effects of Aromatase Inhibition in Obese Men
|ClinicalTrials.gov Identifier: NCT00138710|
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : October 22, 2010
|Condition or disease||Intervention/treatment||Phase|
|Hypogonadotrophic Hypogonadism Obesity||Drug: Letrozole (Femara)||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Short-term Effects of Aromatase Inhibition in Obese Men|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00138710
|Arnhem, Netherlands, 6815 AM|
|Principal Investigator:||Hans de Boer, MD PhD||Rijnstate Hospital, Arnhem, the Netherlands|