MALE HYPOGONADISM MedDRA version: 9.1 Level: SOC Classification code 10014698 MedDRA version: 9.1 Level: SOC Classification code 10007541
Conditions
Interventions
Trade Name: TOSTREX
Pharmaceutical Form: Gel
INN or Proposed INN: Testosterone
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 20-
Sponsors
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Echocardiography assessed ejection fraction =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Age 12 nmol / l or calculated free testosterone> 225 pmol / L. • Known hypersensitivity to any component of the drug used in the study. • History of prostate cancer and breast cancer or suspicion of prostate cancer with digital rectal examination. • Level of PSA> 4 ng / ml. • Level of hematocrit> 50% • Severe obstructive urinary symptoms (score on IPSS> 19)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Improvement in exercise tolerance assessed according to the six minutes walking test.;Secondary Objective: Improvement of ejection fraction assessed by echocardiogram. Improving quality of life assessed by SF-36 questionnaire. Improvement of sexual function assessed by IIEF-5 questionnaire. Improved non-sexual symptoms of hypogonadism assessed through the questionnaire AMS.;Primary end point(s): Considering data in literature, we expect that treatment with testosterone improves exercise tolerance (expected outcome after treatment + 65 m at 6MWT) | — |
Countries
Italy
Outcome results
None listed