Isolated hypogonadotropic hypogonadism related to obesity
Conditions
Interventions
Trade Name: Dianben 850 mg
Product Name: Dianben
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: METFORMIN HYDROCHLORIDE
CAS Number: 1115-70-4
Concentration unit: mg milligram(s)
Concentr
Sponsors
Unidad de Gestión Clínica de Endocrinología y Nutrición
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men aged 18 to 65 years. 2. BMI ? 30 kg/m2. 3. Total testosterone levels =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of testosterone undecanoate, metformin, or the combination of both, for the treatment of isolated hypogonadotropic hypogonadism and erectile dysfunction in obese males. The main outcome is: - Changes in IIEF (International Index of Erectile Disfunction) score after 52 weeks of treatment.;Secondary Objective: Secondary outcomes are: -Changes in AMS (Aging Males Symptoms) score after 52 weeks of treatment. - Cahnges in ADAM (Androgen Deficiency in the Aging Male) after 52 weeks of treatment. - Changes in the concentrations of total testosterone and free testosterone after 52 weeks of treatment. - Changes in BMI after 52 weeks of treatment. - Changes in concentrations of fat mass and lean mass (measured by multifrequency bioelectrical impedance electrical) after 52 weeks of treatment. - Changes in the levels of insulin and HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) after 52 weeks of treatment.;Primary end point(s): - Changes in the IIEF (International Index of Erectile Function) score after 52 weeks of treatment.;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Changes in the AMS (Aging Males Symptoms) score after 52 weeks of treatment. - Changes in the ADAM (Androgen Deficiency in the Aging Male) score after 52 weeks of treatment. - Changes in the concentrations of total testosterone and free testosterone after 52 weeks of treatment. - Changes in BMI after 52 weeks of treatment. - Changes in concentrations of fat mass and lean mass (measured by multifrequency bioelectrical impedance electrical) after 52 weeks of treatment. - Changes in the levels of insulin and HOMA-IR (Homeostatic Model Assessment of Insulin Resistence) after 52 weeks of treatment.;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Countries
Spain
Contacts
Public ContactUGC Endocrinologia y Nutrición
Unidad de Gestión Clínica de Endocrinología y Nutrición
Outcome results
None listed