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Short-term Effects of Aromatase Inhibition in Obese Men

This study has been completed.
Sponsor:
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT00138710
First received: August 29, 2005
Last updated: October 21, 2010
Last verified: October 2010
History of Changes

August 29, 2005
October 21, 2010
August 2005
January 2010   (final data collection date for primary outcome measure)
  • 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)
Same as current
Complete list of historical versions of study NCT00138710 on ClinicalTrials.gov Archive Site
  • Lipid profile
  • Blood counts
  • Bone markers
  • Liver enzymes
Same as current
Not Provided
Not Provided
 
Short-term Effects of Aromatase Inhibition in Obese Men
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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Hypogonadotrophic Hypogonadism
  • Obesity
Drug: Letrozole (Femara)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI between 35 and 50
  • Male sex
  • Ages between 20 and 50
  • Serum total testosterone under 10 nmol/l
  • Serum luteinizing hormone (LH) under 9 mU/l
  • Serum estradiol over 40 pmol/l

Exclusion Criteria:

  • Comorbidity
  • Serum prostate-specific antigen (PSA) over 4.0 U/l
  • Discontinuation of smoking less than six months ago
  • Medication known to affect hormonal parameters
Male
20 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00138710
LTC-323-150405
Not Provided
Not Provided
Rijnstate Hospital
Not Provided
Principal Investigator: Hans de Boer, MD PhD Rijnstate Hospital, Arnhem, the Netherlands
Rijnstate Hospital
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP