Hypogonadotrophic Hypogonadism, Obesity
Conditions
Keywords
obesity, Hypogonadotrophic hypogonadism, aromatase inhibition
Brief 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.
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.
Interventions
Sponsors
Rijnstate Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Lipid profile | — |
| Blood counts | — |
| Bone markers | — |
| Liver enzymes | — |
Countries
Netherlands
Outcome results
None listed