Short-term Effects of Aromatase Inhibition in Obese Men

Obesity Clinical Trial

Official title:

Short-term Effects of Aromatase Inhibition in Obese Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00138710
• Other study ID #: LTC-323-150405
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2005
• Last updated: October 21, 2010
• Start date: August 2005
• Est. completion date: January 2010

Study information

• Verified date: October 2010
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadotrophic Hypogonadism
• Obesity

Intervention

Drug:
• Letrozole (Femara)

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight
Primary	Body mass index (BMI)
Primary	Waist circumference
Primary	Body composition
Primary	Exercise capacity
Primary	Serum levels of hormones
Primary	Glucose tolerance
Primary	Reported side effects
Primary	Psychological characteristics (Symptom Checklist, intelligence quotient [IQ] NPV)
Secondary	Lipid profile
Secondary	Blood counts
Secondary	Bone markers
Secondary	Liver enzymes