Obesity, male hypogonadism Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
1. Letrozole 2.5 mg tablet (Femara®) once weekly by oral ingestion for 12 weeks (12 tablets, Test Product).
2. Testosterone undecanoate 1 g injection (Nebido®) every 6 weeks by intramuscular administr
Sponsors
University College Dublin (UCD) (Ireland)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Men who satisfy all of the following may be included in the study: 1. Age between 18 and 65 years inclusive 2. Body mass index (BMI) greater than 30 kg/m2 3. Serum total testosterone concentrations less than 8.0 nmol/L on two consecutive occasions. The blood that will be used for measurement of the testosterone concentrations will be taken from research participants after a 12 hour fast and between the hours of 0800 to 1100. 4. Willingness to voluntarily sign a statement of informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Men with any of the following conditions will be excluded from the study: 1. Use of systemic glucocorticoid, sex hormone or anticoagulant therapy, or a medication known to effect sex hormone bioactivity during the 6 months prior to study entry (i.e., screening visit) 2. Known hypersensitivity to the active substances or any of the excipients of Femara® or Nebido® 3. Hypothalamic pituitary disease 4. Untreated obstructive sleep apnoea syndrome 5. Haemophilia 6. Psychotic mental illness 7. Inability to understand the participant information or to give informed consent 8. History of cancer 9. History of prostatic intra-epithelial neoplasia (PIN) 10. Severe lower urinary tract symptoms (International Prostate Symptom Score greater than 19) 11. Erythrocytosis (haematocrit greater than 0.5, or haemoglobin greater than 17 g/dl) 12. Prostate specific antigen (PSA) level greater than 3 ng/ml 13. Moderate to severe chronic kidney disease (estimated glomerular filtration rate [eGFR] less than 30 ml/min/1.73 m2) 14. Severe liver disease (serum alanine transferase level greater than 150 IU/L) 15. Significant cardiomyopathy (left ventricular ejection fraction less than 30%) 16. Greater than 2 seizures during the 12 months prior to study entry 17. Requiring fertility treatment 18. Any clinically significant chronic disease that might, in the opinion of the investigator, interfere with the evaluations or preclude completion of the trial (e.g., severe chronic lung disease, terminal illness) 19. Previous randomisation into this study 20. Concurrent participation in another clinical trial 21. Participation in another clinical trial during the twelve weeks prior to study entry (i.e. screening visit)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the serum concentration of the pro-inflammatory cytokine, C-reactive protein, measured after 6 and 12 weeks of drug therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured after 12 weeks of drug therapy: 1. The change in the serum concentration of other pro-inflammatory cytokines: interleukin-6 (IL-6), tumour-necrotising factor alpha (TNFa), (interleukin-1-alpha (IL1a), interferon alpha (IFNa) 2. The change in the time taken to walk 500 m at a moderately intense pace 3. The change in erectile function 4. The change in modifiable cardiovascular disease risk factors including blood pressure, glycosylated haemoglobin, insulin resistance (homeostatic model of assessment), lipid fractions and weight 5. The change in quality of life | — |
Countries
Ireland
Outcome results
None listed