Short-term Effects of Aromatase Inhibition in Obese Men

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rijnstate Hospital
• Treatments: Letrozole

Criteria

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