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Completed

NCT Number: NCT00138710

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.

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Key information

Conditions

Hypogonadotrophic Hypogonadism Body Weight Endocrine System Diseases Gonadal Disorders Hypogonadism Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Rijnstate Hospital

Arnhem, 6815 AM, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

letrozole (Femara)

Drug

Primary outcomes

  1. Body weight

  2. Body mass index (BMI)

  3. Waist circumference

  4. Body composition

  5. Exercise capacity

  6. Serum levels of hormones

  7. Glucose tolerance

  8. Reported side effects

  9. Psychological characteristics (Symptom Checklist, intelligence quotient [IQ] NPV)

Secondary outcomes

  1. Lipid profile

  2. Blood counts

  3. Bone markers

  4. Liver enzymes

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Aug 30, 2005
Registry last updated
Oct 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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