Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Letrozole2010-1
Study information
Scientific title
The effects of normalising sex hormone levels in obese hypogonadal men: a prospective randomised comparator controlled parallel arm clinical trial
Acronym
Study hypothesis
Normalising sex hormone levels decreases inflammation in men with obesity related hypogonadism.
Ethics approval
Not provided at time of registration
Study design
Single centre randomised, comparator controlled, parallel arm, open label clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Obesity, male hypogonadism
Intervention
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 administration for 12 weeks (2 injections, Comparator).
Intervention type
Drug
Phase
Phase II
Drug names
Letrozole (Femara®), Testosterone undecanoate (Nebido®)
Primary outcome measures
Change in the serum concentration of the pro-inflammatory cytokine, C-reactive protein, measured after 6 and 12 weeks of drug therapy.
Secondary outcome measures
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
Overall trial start date
15/11/2010
Overall trial end date
30/09/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
90
Participant 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)
Recruitment start date
15/11/2010
Recruitment end date
30/09/2012
Locations
Countries of recruitment
Ireland
Trial participating centre
UCD Clinical Research Centre
Dublin
4
Ireland
Sponsor information
Organisation
University College Dublin (UCD) (Ireland)
Sponsor details
Belfield
Dublin
D4
Ireland
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Research Board (Ireland)
Alternative name(s)
HRB
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Ireland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary