Evalation of the effects of testosterone undecanoate, metformin, or a combination of both, for the treatment of decreased testicular function and erectile dysfunction in obese males

• Conditions: Isolated hypogonadotropic hypogonadism related to obesity; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2012-000870-51-ES
• Lead Sponsor: nidad de Gestión Clínica de Endocrinología y Nutrición

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-14
• Last Update Posted: 11 March 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Men aged 18 to 65 years.
2. BMI ? 30 kg/m2.
3. Total testosterone levels <3.5 ng/dl.
4. LH levels <7.7 mIU / ml.
6. No evidence of any other pituitary hormone disruption in morning blood sample (normal concentrations of TSH, FT4, Prolactin, ACTH, cortisol and IGF-1
7. Being able to provide informed consent before randomization and agree to comply with all the procedures included in the protocol.
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 72
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Intolerance/allergy to metformin or testosterone undecanoate.
2. Previous diagnosis of diabetes mellitus (HbA1c> 6.5% or fasting glucose> 126 mg/dl or glucose> 200 mg/dl after an oral glucose tolerance test)
3. Treatment with oral hypoglycemic agents, insulin or GLP-1 analogs.
4. Poor kidney function: serum creatinine> 2.0 mg / dl.
5. Previous history of prostate cancer or breast cancer.
6. Active cancer of any kind.
7. History of liver tumor or acute or chronic liver disease with impaired liver function: total bilirubin> 2.0 mg / dl or GOT levels three times the upper limit of normal.
8. Central hypogonadism of organic cause
9. Use in the past 12 months of any drug that affects the pituitary-gonadal axis.
10. Use of oral testosterone, oral or transdermal within 2 weeks prior to study entry, or any testosterone ester in the last 6 weeks or testosterone undecanoate injection in the 6 months prior to study entry.
11. Uncontrolled hypertension (SBP> 160 mmHg or DBP> 100 mmHg) despite adequate antihypertensive therapy.
12. HIV infection or known active infection with HBV or HCV.
13. Thrombotic or embolic disease.
14. Heart disease, kidney or liver disease.
15. Epilepsy or migraine not adequately controlled with treatment.
16. Hematocrit> 50% in the screening.
17. PSA> 4 ng / ml.
18. Severe benign prostatic hypertrophy with an IPSS scale score over 19.
19. Evidence of drug or alcohol abuse (> 50 g alcohol / day)
20. Hematological diseases that produce increased risk of bleeding after intramuscular injection.
21. Serious underlying disease that might affect the patient's ability to participate in the study (eg ongoing infection, gastric ulcers, active autoimmune disease).
22. Reduced life expectancy (<12 months) by the presence of comorbidities or advanced terminals.
23. Participation in another clinical trial within 30 days before study entry.
24. Previous diagnosis of hemochromatosis

Study & Design

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