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INTRODUCTION AND OBJECTIVES: It is well known that testosterone plays a critical role in regulation of erectile function (EF). Veno-occlusive insufficiency is a causal or accompanying symptom in 20e45% of patients with ED. The conventional therapy of venogenic ED may be useless if unrecognized andogendeficiency. There are limited data shown that testosterone improves EF in hypogonadal patients with veno-occlusive dysfunction. In this multiclinical study we evaluated the results of testosterone therapy (TT) in the hypogonadal patients with corporal venous leakage.METHODS: 49 hypogonadal men with ED and venous leakage from corpora cavernosa, aged 32 e 56 (44AE8, 3) non-responded to PDE-5 inhibitors, were examined. Comorbidities included diabetes mellitus (4 pts), arterial hypertension (5 pts), alcohol abuse ( 8pts). Testosterone levels were 2,3 -11,2 (6,8AE3,1) nmol/l. After lab tests each patient underwent penile duplex ultrasound for reveling signs of venous deficiency. Arterial inflow was normal at all patients while the end diastolic velocity was >5 ml/sec. All patients underwent the treatment with 1,000 mg testosterone undecanoate on day 1, followed by another injection after 6 weeks and every 3 months thereafter -5 injections totally. Pharmacocavernosography (PCG) (7 pts) or magnetic resonance imaging (MRI) with contrast enhancement (14 pts) were used for visualization of venous leakage pathways prior to TT and after 6 -8 months of TT for the detection of venous leakage decreasing. Design of the investigation: open, prospective, non-control, non-randomize.RESULTS: All patients responded to the therapy and noted the considerable improvement in EF domain (IIEF scores increased to 24,5 AE 0,5) and SD domain (IIEF scores increased to 9 AE 0.3) 41/49 pts (84%) restore satisfactory coitus with monotherapy of testosterone. 8/49 pts (16%) poor responded to monotherapy had satisfactory coitus after combine therapy with PDE-5 inhibitors. After 6 months treatment the control penile duplex ultrasound revealed in 45 pts the end diastolic velocity <5 ml/sec. PCG or MRI was repeated in 12 patients. Compared with baseline investigation, repeat radiological studies after TT showed significant decreasing or even absence of the venous leakage from the corporal bodies.CONCLUSIONS: These results demonstrate that testosterone regulates the veno-occlusive mechanism of erection and improves the EF in hypogonadal patients with venous leakage. The combination of TT with PDE-5 inhibitors will be useful in poor responders to the testosterone monotherapy.