Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/08/2010
Date assigned
06/09/2010
Last edited
06/09/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Frances Hayes

ORCID ID

Contact details

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

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

http://www.ucd.ie/

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

Publication citations

Additional files

Editorial Notes