The Effects of Normalising Sex Hormone Levels in Obese Hypogonadal Men: A Prospective Randomized Comparator Controlled Parallel Arm Clinical Trial - Normalising Sex Hormone Levels in Obese Hypogonadal Me

Phase 1

• Conditions: Obesity Related Male Hypogonadism; MedDRA version: 12.1 Level: LLT Classification code 10029883 Term: Obesity; MedDRA version: 12.1 Level: LLT Classification code 10021011 Term: Hypogonadism male

• Registration Number: EUCTR2010-021268-13-IE
• Lead Sponsor: niversity College Dublin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-11
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 90

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 30kg/m2
3.Serum total testosterone concentrations less than 8.0nmol/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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 >19)
11.Erythrocytosis (Haematocrit > 0.5, or Haemoglobin > 17g/dl)
12.Prostate specific antigen (PSA) level >3ng/ml
13.Moderate to severe chronic kidney disease (eGFR <30ml/min/1.73m2)
14.Severe liver disease (serum Alanine Transferase level >150IU/L)
15.Significant cardiomyopathy (Left ventricular ejection fraction <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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified