Short-term Effects of Aromatase Inhibition in Obese Men
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|