Normalising sex hormone levels in obese hypogonadal men

ISRCTN ISRCTN21665331
DOI https://doi.org/10.1186/ISRCTN21665331
Secondary identifying numbers Letrozole2010-1
Submission date
27/08/2010
Registration date
06/09/2010
Last edited
06/09/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Frances Hayes
Scientific

UCD Clinical Research Centre
St Vincent's University Hospital
Elm Park
Dublin
4
Ireland

Study information

Study designSingle centre randomised, comparator controlled, parallel arm, open label clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe effects of normalising sex hormone levels in obese hypogonadal men: a prospective randomised comparator controlled parallel arm clinical trial
Study objectivesNormalising sex hormone levels decreases inflammation in men with obesity related hypogonadism.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedObesity, male hypogonadism
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Letrozole (Femara®), Testosterone undecanoate (Nebido®)
Primary outcome measureChange in the serum concentration of the pro-inflammatory cytokine, C-reactive protein, measured after 6 and 12 weeks of drug therapy.
Secondary outcome measuresMeasured 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 study start date15/11/2010
Completion date30/09/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexMale
Target number of participants90
Key inclusion criteriaMen 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
Key exclusion criteriaMen 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)
Date of first enrolment15/11/2010
Date of final enrolment30/09/2012

Locations

Countries of recruitment

  • Ireland

Study participating centre

UCD Clinical Research Centre
Dublin
4
Ireland

Sponsor information

University College Dublin (UCD) (Ireland)
University/education

Belfield
Dublin
D4
Ireland

http://www.ucd.ie/
ROR logo https://ror.org/05m7pjf47

Funders

Funder type

Government

Health Research Board (Ireland)
Private sector organisation / Other non-profit organizations
Alternative name(s)
HRB
Location
Ireland

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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