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
  Purpose

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.


Condition Intervention Phase
Hypogonadotrophic Hypogonadism
Obesity
Drug: Letrozole (Femara)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Short-term Effects of Aromatase Inhibition in Obese Men

Resource links provided by NLM:


Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • Lipid profile
  • Blood counts
  • Bone markers
  • Liver enzymes

Estimated Enrollment: 50
Study Start Date: August 2005
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138710

Locations
Netherlands
Rijnstate Hospital
Arnhem, Netherlands, 6815 AM
Sponsors and Collaborators
Rijnstate Hospital
Investigators
Principal Investigator: Hans de Boer, MD PhD Rijnstate Hospital, Arnhem, the Netherlands
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00138710     History of Changes
Other Study ID Numbers: LTC-323-150405
Study First Received: August 29, 2005
Last Updated: October 21, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Rijnstate Hospital:
obesity
Hypogonadotrophic hypogonadism
aromatase inhibition

Additional relevant MeSH terms:
Hypogonadism
Obesity
Gonadal Disorders
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014