RANDOMIZED CLINICAL TRIAL TO ASSESS THE EFFICACY OF TESTOSTERONE UNDECANOATE, METFORMIN, OR THE COMBINATION OF BOTH, FOR THE TREATMENT OF ISOLATED HYPOGONADOTROPIC HYPOGONADISM AND ERECTILE DYSFUNCTION IN OBESE MALES

nidad de Gestión Clínica de Endocrinología y Nutrición0 sitesSeptember 14, 2012

Overview

No summary available.

Registry

who.int

Start Date

September 14, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

nidad de Gestión Clínica de Endocrinología y Nutrición

•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

•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.