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Extrait
The primary objective of the double blind phase is to compare the effect of testosterone solution vs. placebo on the proportion of hypogonadal men having a serum total testosterone concentration within the normal range (300 – 1050 ng/dL) at the completion of 12 weeks of treatment. The primary objective of the open-label extension phase is to assess the safety of testosterone solution for an additional 24 weeks in hypogonadal men using the following measures: • Adverse events • Clinical laboratory tests (including hematocrit) • Prostate safety (prostate specific antigen [PSA] and digital rectal exam) • International Prostate Symptom Score (IPSS)
Critère d'inclusion
- Male hypogonadism